Basic Purpose and Function:
Independently perform quality-related functions within the Quality Department. Maintain and monitor quality systems, including document control, change control, CAPA (Corrective and Preventive Actions), internal audits, and complaint handling.
Job Responsibilities:
· Manages the review cycle of customer complaints and CAPA’s
· Lead internal audit program
· Assist in the development, revision, and control of Standard Operating Procedures (SOPs) and other controlled documents.
· Identify training needs and conduct Quality Assurance-related training to associates in tandem with the Quality Manager
· Facilitate the nonconformance process and ensure timely investigation, root cause analysis, and resolution.
· Supports the maintenance and upkeep of the Quality Management System
· Support performance metrics system for continual improvement
· Assist with inspections, document reviews, and data entry when additional support is required to maintain production or quality timelines
Other Responsibilities:
· Responsible for adhering to the quality system and good manufacturing procedures
· Must be able to communicate effectively with the supervisor and co-workers to provide and receive directions
· Demonstrate good time management skills independent of supervision
· Maintain timely and regular attendance per company policy
· Performs other duties as assigned
Qualifications:
· Associates degree or equivalent; or 3-5 years related experience and or training; or equivalent combination of education and experience in medical device manufacturing
· Proficient in applicable regulations/standards (ISO 13485, FDA, etc.)
· Ability to read, analyze, and interpret general business periodicals, professional journals, or governmental regulations.
· Ability to write reports, business correspondence, and procedure manuals
· Ability to effectively present information and respond to questions from employees, supervisors, managers, executive staff, customers, and suppliers
· Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing and repetitive motions
· Proficiency in Microsoft Word, Excel, and Outlook or similar e-mail programs
· Responsible for adhering to the quality system and good manufacturing procedures
· Must be able to communicate effectively with the manager and co-workers to provide and receive direction
· Demonstrate good time management skills independent of supervision
· Maintain timely and regular attendance per company policy
Physical Requirements:
· Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing and repetitive motions
· The associate must occasionally lift and/or move up to 40 pounds
· Specific vision abilities required by this job include close vision and the ability to adjust focus
PI285674469
Read LessTitle: Quality Assurance Technician I
Basic Purpose and Function:
The Quality Assurance Technician I is responsible for performing multiple functions, including ensuring the integrity and quality of products being produced and shipped to customers. The employee will be responsible for performing a variety of tests to determine the suitability of products and processes. Work is performed in production and testing areas.
Job Responsibilities:
Verify and approve job set-ups for Converting.Conduct in-process inspections and rework reporting.Read and understand traveler requirements.Perform product testing per company or customer requirements. (Water, Air, Burst)Participate in Quality & Safety programs (5S, Stop Audits).Understand documentation and testing requirements for medical device products.Communicate non-conformances discovered to the appropriate department to initiate corrective action.ISO 13485 and food safety compliance.Other Responsibilities:
Must be able to communicate effectively with Supervisor and co-workers to provide and receive direction.Demonstrate good time management skills independent of supervision.Maintain timely and regular attendance per company policy.Must have flexibility to work varying hours and shifts, including overtime as needed.Perform other duties as assigned by QC SupervisorQualifications:
Basic math and computer skills (Word, Excel)Ability to read, write, and communicate in EnglishPhysical Requirements:
Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing and repetitive motions.This position is frequently required to use hands to handle or feel objects, tools or controls, and reach with hands and arms.Ability to stand/move 8-12 hours per day.The associate must occasionally lift and/or move up to 40 pounds.Specific vision abilities required by this job include close vision and the ability to adjust focus.Job Title: Production and Operations Shift Supervisor
Location: Vonco Products
Job Type: Full-Time
Second Shift: 2 pm - midnight. Monday - Thursday. On-site in Fortville, IN, all days of work.
Position Overview:
We are seeking a dynamic, compassionate Second Shift Supervisor to lead our teams with some flexibility to work across shifts as needed. As a leader, you'll play a key role in driving both production success and our team's well-being. This position requires a balance of strong managerial skills, operational expertise, and a genuine focus on people. We're seeking someone committed to fostering a supportive and respectful environment where employees feel valued and motivated to succeed.
If you enjoy building relationships with your team, mentoring employees, and taking charge of the operational aspects of a flexible packaging production line, this could be the perfect role for you.
Key Responsibilities:
• Team Leadership & Employee Engagement:
Foster a positive, collaborative environment by building strong connections with all team members.
Act as a resource for employees, providing guidance, coaching, and addressing concerns.
Engage in regular one-on-one check-ins with team members to ensure their needs and development goals are being met.
Cultivate a culture of mutual respect, communication, and accountability.
Recognize and celebrate team achievements to create a motivated and productive atmosphere.
• Production Management:
Supervise and coordinate day-to-day production floor operations, ensuring efficiency and adherence to quality standards.
Monitor and adjust production processes to meet deadlines while maintaining safety and quality standards.
Implement and track key performance indicators (KPIs) for production targets, quality control, and waste reduction.
• Safety & Compliance:
Ensure adherence to safety regulations and company policies to maintain a safe work environment.
Proactively address any safety concerns and provide timely corrective action when necessary.
Ensure all employees are appropriately trained on safety protocols and maintain up-to-date certifications as required.
• Problem-Solving & Continuous Improvement:
Troubleshoot production issues and make quick, informed decisions to minimize downtime.
Work with cross-functional teams to identify process improvements and drive operational efficiency.
Analyze production data to identify trends, problems, and optimization opportunities.
• Administrative and Reporting Duties:
Maintain accurate records of daily production activities, employee attendance, and quality metrics.
Assist with scheduling, resource allocation, and performance reviews.
Handle employee time-off requests and ensure smooth shift transitions.
2nd Shift. The second shift hours typically run from 2 PM to midnight. Often, shift supervisors need to arrive before a shift starts and leave after it ends to ensure a proper handover between shifts.
Reporting: This role reports to the Plant Manager. This role oversees production cell leads, shift leads, and all shift team members.
Qualifications: Experience
o 3-5 years of experience in a supervisory role within the packaging or manufacturing industry.
o Prior experience managing and leading teams, with a focus on employee development.
o Strong understanding of packaging processes, equipment, and materials preferred.
• Skills:
o Strong leadership abilities with a focus on building relationships and trust within a team.
o Excellent communication and interpersonal skills.
o Strong problem-solving skills with the ability to address operational challenges effectively.
o Ability to manage multiple tasks simultaneously while maintaining attention to detail.
o Proficiency in using production management software and Microsoft Office Suite.
o Bilingual, Spanish and English language skills preferred.
• Leadership Attributes:
o Empathetic and approachable, able to connect with employees at all levels.
o High level of integrity and professionalism.
o Motivated to improve the work environment and take initiative in leading change.
Safety Requirements
The employee’s position involves operating industrial manufacturing equipment and working around:
Heavy-duty converting machinesPlastic slitters and cutting equipmentMoving mechanical partsThese duties require the employee to maintain situational awareness and follow workplace safety procedures to protect themselves and other employees.
Why Join Us?
• Growth Opportunities: As part of a thriving company, there is ample opportunity for you to grow professionally, with room for advancement and development.
• Competitive Pay & Benefits: We offer competitive compensation packages, including benefits like medical, vision, and dental insurance, 401 (k) retirement plans, and paid tuition reimbursement.
• 3-day weekends. Four 10-hour shifts weekly work schedule, Mon - Thursday.
Title: Quality Assurance Technician I
Basic Purpose and Function:
The Quality Assurance Technician I is responsible for performing multiple functions, including ensuring the integrity and quality of products being produced and shipped to customers. The employee will be responsible for performing a variety of tests to determine the suitability of products and processes. Work is performed in production and testing areas.
Job Responsibilities:
Verify and approve job set-ups for Converting.Conduct in-process inspections and rework reporting.Read and understand traveler requirements.Perform product testing per company or customer requirements. (Water, Air, Burst)Participate in Quality & Safety programs (5S, Stop Audits).Understand documentation and testing requirements for medical device products.Communicate non-conformances discovered to the appropriate department to initiate corrective action.ISO 13485 and food safety compliance.Other Responsibilities:
Must be able to communicate effectively with Supervisor and co-workers to provide and receive direction.Demonstrate good time management skills independent of supervision.Maintain timely and regular attendance per company policy.Must have flexibility to work varying hours and shifts, including overtime as needed.Perform other duties as assigned by QC SupervisorQualifications:
Basic math and computer skills (Word, Excel)Ability to read, write, and communicate in EnglishPhysical Requirements:
Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing and repetitive motions.This position is frequently required to use hands to handle or feel objects, tools or controls, and reach with hands and arms.Ability to stand/move 8-12 hours per day.The associate must occasionally lift and/or move up to 40 pounds.Specific vision abilities required by this job include close vision and the ability to adjust focus.PI285590614
Read LessJob Title: Production and Operations Shift Supervisor
Location: Vonco Products
Job Type: Full-Time
Second Shift: 2 pm - midnight. Monday - Thursday. On-site in Fortville, IN, all days of work.
Position Overview:
We are seeking a dynamic, compassionate Second Shift Supervisor to lead our teams with some flexibility to work across shifts as needed. As a leader, you'll play a key role in driving both production success and our team's well-being. This position requires a balance of strong managerial skills, operational expertise, and a genuine focus on people. We're seeking someone committed to fostering a supportive and respectful environment where employees feel valued and motivated to succeed.
If you enjoy building relationships with your team, mentoring employees, and taking charge of the operational aspects of a flexible packaging production line, this could be the perfect role for you.
Key Responsibilities:
• Team Leadership & Employee Engagement:
Foster a positive, collaborative environment by building strong connections with all team members.
Act as a resource for employees, providing guidance, coaching, and addressing concerns.
Engage in regular one-on-one check-ins with team members to ensure their needs and development goals are being met.
Cultivate a culture of mutual respect, communication, and accountability.
Recognize and celebrate team achievements to create a motivated and productive atmosphere.
• Production Management:
Supervise and coordinate day-to-day production floor operations, ensuring efficiency and adherence to quality standards.
Monitor and adjust production processes to meet deadlines while maintaining safety and quality standards.
Implement and track key performance indicators (KPIs) for production targets, quality control, and waste reduction.
• Safety & Compliance:
Ensure adherence to safety regulations and company policies to maintain a safe work environment.
Proactively address any safety concerns and provide timely corrective action when necessary.
Ensure all employees are appropriately trained on safety protocols and maintain up-to-date certifications as required.
• Problem-Solving & Continuous Improvement:
Troubleshoot production issues and make quick, informed decisions to minimize downtime.
Work with cross-functional teams to identify process improvements and drive operational efficiency.
Analyze production data to identify trends, problems, and optimization opportunities.
• Administrative and Reporting Duties:
Maintain accurate records of daily production activities, employee attendance, and quality metrics.
Assist with scheduling, resource allocation, and performance reviews.
Handle employee time-off requests and ensure smooth shift transitions.
2nd Shift. The second shift hours typically run from 2 PM to midnight. Often, shift supervisors need to arrive before a shift starts and leave after it ends to ensure a proper handover between shifts.
Reporting: This role reports to the Plant Manager. This role oversees production cell leads, shift leads, and all shift team members.
Qualifications: Experience
o 3-5 years of experience in a supervisory role within the packaging or manufacturing industry.
o Prior experience managing and leading teams, with a focus on employee development.
o Strong understanding of packaging processes, equipment, and materials preferred.
• Skills:
o Strong leadership abilities with a focus on building relationships and trust within a team.
o Excellent communication and interpersonal skills.
o Strong problem-solving skills with the ability to address operational challenges effectively.
o Ability to manage multiple tasks simultaneously while maintaining attention to detail.
o Proficiency in using production management software and Microsoft Office Suite.
o Bilingual, Spanish and English language skills preferred.
• Leadership Attributes:
o Empathetic and approachable, able to connect with employees at all levels.
o High level of integrity and professionalism.
o Motivated to improve the work environment and take initiative in leading change.
Safety Requirements
The employee’s position involves operating industrial manufacturing equipment and working around:
Heavy-duty converting machinesPlastic slitters and cutting equipmentMoving mechanical partsThese duties require the employee to maintain situational awareness and follow workplace safety procedures to protect themselves and other employees.
Why Join Us?
• Growth Opportunities: As part of a thriving company, there is ample opportunity for you to grow professionally, with room for advancement and development.
• Competitive Pay & Benefits: We offer competitive compensation packages, including benefits like medical, vision, and dental insurance, 401 (k) retirement plans, and paid tuition reimbursement.
• 3-day weekends. Four 10-hour shifts weekly work schedule, Mon - Thursday.
PI285590691
Read LessJob Title: Design Engineer
Location: Trevor, WI or Fortville, IN (Required to be On-Site)
Department: Design Engineering
Come join a team that cares more about each other, customers, patients, and consumers. Our products impact people’s lives dramatically – that’s why we care so much. In this role, you will design packaging and products with and for leading healthcare and consumer product companies.
Vonco is a leading contract manufacturer for healthcare and consumer products. In healthcare, the industries served include fluid transfer containers, specimen collection and transportation, personal protective equipment and supplies, packaging, and infection prevention. For consumers, leading products include fluid, shaped, and sustainable packaging.
Job Purpose:
Designs and integrate custom products and packaging to meet customer expectations. Engage with sales and customers to identify critical design inputs and develop solutions to meet customer needs. Provides design engineering support of new products and packaging, including capital, through the design and development (DISCOVERY, SPARKS, and Road Maps to Commercialization), trials, and commercialization stages.
The engineer will work cross-functionally with Operations, Quality, Design Engineering, and customers to support new product introductions, process improvements, equipment qualifications, and ongoing manufacturing validation activities.
Design Engineering Job Duties:
Technical team member capable of designing flexible packaging or devices. Has the ability to estimate cost (by building a bill of materials and manufacturing sets) and present proposals (design assumptions, risks, timeline, and cost) to customers. Experience and working knowledge in plastic welding (heat, ultrasonic, or radio-frequency welding) for various flexible materials (PE, PP, PVC, …) Proven track record for Design of Manufacturability assessments. Has the ability to take novel concepts and recommend design changes (material and geometric design) to be manufactured effectively Create hand samples using prototyping equipment to show customers existing designs and changes to the concept to support manufacturability Leads a cross-functional project team through all phases of the product development process. Identify product designs and solutions to meet customer needs. Design multiple options (different geometric designs and materials) Partnering with Operations to understand manufacturing capabilities and equipment capacity, and ensuring that new products are designed for manufacturing.Create design and development plans, design inputs, outputs, and risk management files. Support the design transfer of new products to production Provide planning for complex product development and scale-up.Supports the integration of new products (completing Design Contract Reviews, Product Master Drawings, Quality Planning Checklist, Web Layouts, Lamination and Slitting Instructions) Working with the process engineering team for manufacturing and validating manufacturing processes, as well as creating material specifications.Maintains product and company reputation by complying with government regulations.Maintains system and product information, including quotes and drawings.Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.Able to communicate effectively with customers, co-workers, and be able to work across various personnel levelsRequired Qualifications
· BS degree in Engineering or related field; or equivalent combination of education and experience
· 3-5 years in the engineering field
· Proficient in AutoCAD (or any similar type of engineering design software)
· Good mechanical aptitude and problem-solving skills
• Strong technical writing and documentation skills.
· Ability to sit/walk/stand for 8 hours/day and lift 50 lbs.
· Ability to Travel (up to 10-20%)
Preferred Qualifications
• Experience in flexible films, medical packaging, or converting operations.
• Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.
• Experience supporting customer inquiries and inspections preferred.
Key Competencies
• Strong analytical and problem-solving skills
• Project management and organizational skills
• Attention to detail and documentation accuracy
• Effective communication and collaboration skills
• Ability to manage multiple priorities in a fast-paced manufacturing environment
• Customer-focused mindset
• Team Player, positive attitude!
PI285590641
Read LessJob Title: Design Engineer
Location: Trevor, WI or Fortville, IN (Required to be On-Site)
Department: Design Engineering
Come join a team that cares more about each other, customers, patients, and consumers. Our products impact people’s lives dramatically – that’s why we care so much. In this role, you will design packaging and products with and for leading healthcare and consumer product companies.
Vonco is a leading contract manufacturer for healthcare and consumer products. In healthcare, the industries served include fluid transfer containers, specimen collection and transportation, personal protective equipment and supplies, packaging, and infection prevention. For consumers, leading products include fluid, shaped, and sustainable packaging.
Job Purpose:
Designs and integrate custom products and packaging to meet customer expectations. Engage with sales and customers to identify critical design inputs and develop solutions to meet customer needs. Provides design engineering support of new products and packaging, including capital, through the design and development (DISCOVERY, SPARKS, and Road Maps to Commercialization), trials, and commercialization stages.
The engineer will work cross-functionally with Operations, Quality, Design Engineering, and customers to support new product introductions, process improvements, equipment qualifications, and ongoing manufacturing validation activities.
Design Engineering Job Duties:
Technical team member capable of designing flexible packaging or devices. Has the ability to estimate cost (by building a bill of materials and manufacturing sets) and present proposals (design assumptions, risks, timeline, and cost) to customers. Experience and working knowledge in plastic welding (heat, ultrasonic, or radio-frequency welding) for various flexible materials (PE, PP, PVC, …) Proven track record for Design of Manufacturability assessments. Has the ability to take novel concepts and recommend design changes (material and geometric design) to be manufactured effectively Create hand samples using prototyping equipment to show customers existing designs and changes to the concept to support manufacturability Leads a cross-functional project team through all phases of the product development process. Identify product designs and solutions to meet customer needs. Design multiple options (different geometric designs and materials) Partnering with Operations to understand manufacturing capabilities and equipment capacity, and ensuring that new products are designed for manufacturing.Create design and development plans, design inputs, outputs, and risk management files. Support the design transfer of new products to production Provide planning for complex product development and scale-up.Supports the integration of new products (completing Design Contract Reviews, Product Master Drawings, Quality Planning Checklist, Web Layouts, Lamination and Slitting Instructions) Working with the process engineering team for manufacturing and validating manufacturing processes, as well as creating material specifications.Maintains product and company reputation by complying with government regulations.Maintains system and product information, including quotes and drawings.Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.Able to communicate effectively with customers, co-workers, and be able to work across various personnel levelsRequired Qualifications
· BS degree in Engineering or related field; or equivalent combination of education and experience
· 3-5 years in the engineering field
· Proficient in AutoCAD (or any similar type of engineering design software)
· Good mechanical aptitude and problem-solving skills
• Strong technical writing and documentation skills.
· Ability to sit/walk/stand for 8 hours/day and lift 50 lbs.
· Ability to Travel (up to 10-20%)
Preferred Qualifications
• Experience in flexible films, medical packaging, or converting operations.
• Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.
• Experience supporting customer inquiries and inspections preferred.
Key Competencies
• Strong analytical and problem-solving skills
• Project management and organizational skills
• Attention to detail and documentation accuracy
• Effective communication and collaboration skills
• Ability to manage multiple priorities in a fast-paced manufacturing environment
• Customer-focused mindset
• Team Player, positive attitude!
Basic Purpose and Function: Accountable for providing Human Resources support to all associates and site leadership through effective communication and administration across all functions of the facility. Under the direction of the HR Director the Human Resources Generalist leads recruitment, employee development, labor relations, policy application, compensation administration, and legal compliance across Vonco Plant sites.
Job Responsibilities
Ensure the culture & working environment are following the established Cultural Operating PrinciplesServe as the main point of contact for all HR related questions and requestsProcess bi-weekly payroll and complete reconciliations, and provide payroll back up support as neededAttract, develop, recognize, and retain employees to support the company’s business needs. Participate in developing organizational guidelines, policies, and procedures.Lead full-cycle recruiting and staffing efforts to ensure the site staffing attainment is met. Support culture survey roll-out to associates and actions/ results and areas for improvement Lead key interface with site leaders on all tools available that will assist individual and team performance improvement at all levels. Provide guidance and mentorship to site leadership on all people management and development issues.Complete all new hire onboarding and corresponding paperwork and administrative setup.Establish and maintain working relationships with (and between) managers, supervisors, and associates. Build and maintain relations with associates at the manufacturing site, to promote and foster an environment of open communication and transparent, candid feedback. Conduct investigations, provide coaching and document findings, when required. Ensure all EEO compliance is being implemented successfully. Maintain accurate record of training matrix.Coordinate associate development plans performance management Lead benefit orientations and open enrollment activities. Coordinate ongoing training for all staff, including yearly OSHA safety trainingsProduce and submit reports on general HR activity. Maintain compliance of all Vonco’s associates policies. Serve as an active and collaborative member of the HR team Experience using / HRIS systems is a plus. Conduct wage surveys and labor market analysis to ensure competitive compensation practices and support government reporting requirements.Prepares employee separation notices and related documentation, and conducts exit interviews to determine reasons behind separations.Administers benefits programs such as life, health, dental, and disability insurances, pension plans, vacation, sick leave, FMLA leave of absence, and employee assistance.Administers performance review program to ensure effectiveness, compliance, and equity within the organization.Recruits, interviews, tests, and select qualified candidates for both hourly and salaried positions.Requirements:Qualifications
Bachelor’s degree in human resources or related. 3-5 years of experience as an HR Generalist.Deep understanding of Labor Law and employment equity regulations. Efficient HR administration and people management skills. Excellent record-keeping skills. Knowledge of HR functions and best practices. Excellent written and verbal communication skills. Ability to work with a wide variety of people at varying levels of the organization. Works comfortably under pressure and meets tight deadlines. Superb computer literacy with capability in email, MS Office, and related HR software.Remarkable organizational and conflict management skills. Strong decision-making and problem-solving skills. Attention to detail, focused on driving business results Bilingual in English and Spanish strongly preferred. Read LessIntegration (Process Validation) Engineer
Medical Device Contract Manufacturer – Flexible Films & Packaging
Position Summary
The Integration (Process Validation) Engineer is responsible for leading and supporting process validation and manufacturing integration activities for medical device packaging, flexible film converting, and related manufacturing processes. This role ensures manufacturing processes are developed, validated, transferred, and maintained in compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, customer requirements, and internal quality standards.
The engineer will work cross-functionally with Operations, Quality, Design Engineering, and customers to support new product introductions, process improvements, equipment qualifications, and ongoing manufacturing validation activities.
Reporting Structure
• Reports To: VP of Quality and Integration Engineering
• Department: Integration Engineering
Essential Duties and Responsibilities
• Develop and execute IQ, OQ, and PQ validation protocols and reports.
• Lead validation activities for flexible film converting, RF welding, heat sealing, pouch manufacturing, printing, and labeling operations.
• Perform process capability studies and statistical analysis to support validation activities.
• Establish process windows, critical process parameters, and acceptance criteria.
• Support new product introductions (NPI) from concept through commercial production.
• Identify and implement process improvements focused on quality, efficiency, scrap reduction, and throughput.
• Lead root cause investigations and corrective actions related to process performance.
• Ensure compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485, GMP requirements, and customer-specific quality requirements.
• Support internal, customer, and regulatory audits.
Project Management & Customer Communication
• Lead cross-functional project activities related to process validation, equipment implementation, and new product integration.
• Develop and manage project timelines, deliverables, and validation schedules to support customer and internal milestones.
• Coordinate activities between Engineering, Quality, Operations, Supply Chain, and customer teams to ensure successful project execution.
• Serve as a primary technical point of contact for customers during new product introductions, validation activities, process transfers, and ongoing manufacturing support.
• Communicate project status, technical risks, validation progress, and issue resolution plans to internal leadership and customers.
• Facilitate customer meetings, technical reviews, and validation planning discussions.
• Support quotation reviews and provide technical input related to manufacturability, process capability, and validation requirements.
• Collaborate with customers to understand product requirements, critical-to-quality characteristics, and regulatory expectations.
• Support customer visits, audits, factory acceptance activities, and production trials as needed.
Required Qualifications
• Bachelor’s degree in Engineering or related technical field required.
• 3+ years of engineering experience in a regulated manufacturing environment.
• Experience with process validation in regulated manufacturing.
• Working knowledge of IQ/OQ/PQ methodologies, statistical analysis, root cause analysis tools, and risk management methodologies.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.
• Strong technical writing and documentation skills.
Preferred Qualifications
• Experience in flexible films, medical packaging, or converting operations.
• Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.
• Experience supporting customer audits and regulatory inspections.
• Experience with EQMS systems.
Key Competencies
• Strong analytical and problem-solving skills
• Project management and organizational skills
• Attention to detail and documentation accuracy
• Effective communication and collaboration skills
• Ability to manage multiple priorities in a fast-paced manufacturing environment
• Customer-focused mindset
Read Less