Essential Job Functions:
Passion:
Passion:People & Technical LeadershipLead and develop Manufacturing and Quality Engineers to build strong technical capability, accountability, and engagement. Foster a culture of ownership and continuous learning while strengthening technical depth, decision-making rigor, and succession readiness.Operational & Business ExcellenceChampion engineering and quality excellence through disciplined execution, robust processes, and proactive risk management. Ensure engineering resources are effectively aligned to support production, NPI, CapEx, and strategic initiatives.
Trustworthiness:Quality LeadershipEnsure manufacturing and quality engineering activities comply with applicable regulatory and quality system requirements (e.g., ISO 13485, FDA QSR, GxP). Serve as a trusted leader for audits, inspections, and customer quality engagementsContinuous Improvement & Risk ManagementPartner cross-functionally to deliver responsive, data-driven engineering and quality support. Serve as the escalation point for complex process, quality, and customer issues, ensuring disciplined change management to protect quality and delivery.
Drive Results:Problem Solving & Corrective ActionLead and support root cause investigations, CAPAs, and continuous improvement initiatives to eliminate defects, reduce variation, and prevent recurrence.Project & Resource ManagementPrioritize and balance engineering and quality workloads to support production needs, NPI, and strategic initiatives.
Collaboration:Cross-Functional PartnershipAlign engineering and quality efforts with site and company objectives through strong cross-functional partnership. Lead engineering and quality execution for NPI, ensuring manufacturability, robust validation, and scalable inspection strategies.Skills:
Strong people leadership and coaching capabilitiesDeep technical expertise in machining-intensive manufacturing environments (CNC turning, Swiss lathes, CNC grinding, secondary operations) and quality inspectionExpertise in root cause analysis, CAPA, PFMEA, control plans, and validationStrong project management, prioritization, and decision-making skillsAbility to interpret data, manage risk, and drive fact-based decisionsExcellent communication skills; ability to influence across levels and functionsExperience:
8-12+ years of experience in machining-focused manufacturing engineering within a regulated or high-precision environment (medical device, aerospace, automotive, or similarpreferred)5+ years of people leadership or technical team leadership experienceDemonstrated hands-on experience with CNC machining processes, including process development, troubleshooting, and production supportExperience with regulated manufacturing environment and quality systems such as ISO 13485 or FDA QSR, GxP, validation protocols, and audit readinessEducation: Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related technical field.
Licenses/Certification: Certifications such as Six Sigma, Lean Manufacturing, or ASQ credentials preferred.Technology/Equipment: Microsoft Office Applications and familiarity with manufacturing software systems (MES, ERP, process monitoring tools)Physical Demands:
Ability to work in both office and manufacturing environments for extended periodsOccasional lifting and/or moving of up to 20 lbs. (fixtures, tooling, small equipment)Must be able to wear Personal Protective Equipment (PPE) as required in manufacturing areas.Excellent visual acuity for inspection, reading drawings, and reviewing documentation.Ability to hear and communicate clearly in meetings, on calls, and during team discussions.Working Conditions:
Primarily office-based with regular time spent on the production floor and in controlled manufacturing environments.Standard Monday–Friday schedule, with flexibility to support production needs or project milestones.Frequent interaction with manufacturing equipment, processes, and cross-functional teamsReporting Structure:
This position reports to the Director of Engineering
Work Location: In person
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Job Title: Accounting Manager
Department: Finance & Accounting
Reports To: Controller / Chief Financial Officer (CFO)
Location: [City, State]
Employment Type: Full-time
Position Summary
The Accounting Manager oversees the day-to-day accounting operations of the company to ensure the accurate and timely preparation of financial information. This role is responsible for managing all day-to-day accounting functions including AP, AR, cash management and fixed assets, maintaining proper internal controls, supporting HR with payroll processing (ADP) and facilitating financial audits with our external auditors. This role will drive the month end close processes and assist the Controller with monthly, quarter and annual financial reporting and will support the Controller with cost accounting, budgeting and forecast activities as needed.
Key Responsibilities
Financial Management & Reporting
Oversee all general ledger activities, including journal entries, reconciliations, and month-end/year-end closing processes.Manage Accounts Payable and Accounts Receivable activities, focusing on cash flow objectivesEnsure compliance with accounting principles (GAAP/IFRS) and internal policies.Cost Accounting & Manufacturing Operations Support (as needed, in collaboration with the Controller)
Assist with management of product costing, standard cost updates, and variance analysis (materials, labor, and overhead).Collaborate closely with operations, procurement, and production teams to monitor inventory accuracy and control production costs.Assist with analysis of manufacturing KPIs to support strategic decision-making.Internal Controls & Compliance
Develop, implement, and monitor effective internal controls to safeguard company assets.Coordinate and prepare for annual audits, tax filings, and compliance reporting.In collaboration with the Controller, maintain compliance with all relevant financial, tax, and industry regulations.Team Leadership
Supervise and mentor accounting staff, providing guidance on professional development and performance goals.Delegate and review work to ensure accuracy and efficiency.Foster collaboration across departments to support continuous improvement.Qualifications
Education & Experience
Bachelor’s degree in Accounting, Finance, or related field required; CPA or CMA preferred.10+ years of progressive accounting experience, with at least 4 years in a supervisory or management role.Previous experience in a manufacturing environment strongly preferred.Proficiency with accounting software (e.g., SAP, Oracle, Sage, or NetSuite) and advanced Excel skills.Skills & Abilities
Strong understanding of cost accounting and inventory management principles.Exceptional analytical, problem-solving, and organizational skills.High attention to detail with the ability to meet deadlines in a fast-paced environment.Excellent communication and leadership abilities.Work Environment
On-site role.Standard office hours, with possible extended hours during closing periods, audits or to meet other deadlines as needed.Compensation & Benefits
Competitive salary commensurate with experience.Comprehensive benefits package, including health, dental, and retirement plans.Paid time off and performance-based incentives.Read Less
We are seeking a seasoned and strategic Quality Systems Project Manager. This is a non-people leader role. The Quality Systems Project Manager role will lead a quality system value stream to achieve excellence in safety, quality, delivery, and cost in a medical device manufacturing environment. This role is responsible for developing processes to ensure suitability of key customer accounts, non-conformance investigation/CAPA, complaints, scorecards and KPI trending, and internal / external audits. The ideal candidate embodies our values of passion, trustworthiness, result-oriented, and togetherness using them to guide effective impactful outcomes. This candidate should demonstrate professionalism, integrity, accountability, and a strong work ethic in all interactions.
Essential Job Functions:
Project Management:Lead complex quality projects, including validations, root cause investigations, and CAPA’s for multiple medical device product lines.Manage and standardize customer requirements while communicating with internal / external stakeholders.Collaboration:Manage the analysis and investigation of products complaints and non-conformancesDrive solution plans to completion by working with a cross functional teamSet Direction and Drive Results:Clearly communicate goals and expectations from key customers with internal team.Utilize continuous improvement principles to propose and implement changes to existing processes aimed at streamlining and improving overall performance.Maintain cost controls, creating cost effective use of resources, and ensuring quality.Lead internal and external audits, including supplier and customer audits, and prepare comprehensive audit reports and CAPA responses.Support training, internal and external audits, including FDA, ISO and Customers.Additional functions may be added at discretion of Management.REQUIREMENTS
SKILLS:
Strong leadership and team-building skillsExcellent written and verbal communicationProblem-solving and decision-making ability under pressureProficient in interpreting production metrics and KPIsComfortable providing briefings at all levels of management.Excellent organizational and time management skillsProficiency in Microsoft Office Suite (Word, Excel, Outlook, Teams, etc.)Strong organizational and multitasking abilitiesAbility to maintain discretion and handle confidential information professionallyEXPERIENCE:
10 plus years of experience in manufacturing or production operations, preferably within the medical device or pharmaceutical industryMinimum of 5 years in a leadership or project management role, ideally within a value stream or lean manufacturing environmentExperience with FDA QSR (21CFR820), ISO 13485, GxP and validation processes preferredEDUCATION:
Education: Bachelor’s degree in engineering, science or equivalent technical experience.Licenses/Certificates: Industry Quality Certifications (i.e., ASQ, PMP)Technology/Equipment: Microsoft Office Applications, Warehouse Management Applications, eQMS softwarePHYSICAL DEMANDS:
Ability to sit or stand and move within an office environment for extended periods of timeMust be able to occasionally lift and/or move up to 20 lbs.Ability to wear Personal Protective Equipment as requiredVisual acuity to inspect parts, read documents, computer screens, etc.Ability to hear and verbally communicate clearly in meetings, on the phone, and in group discussionsOccasional bending, stooping, or reaching during on-site activities or workspace organization.WORKING CONDITIONS:
Office-based role with regular interaction in manufacturing and cleanroom environmentsMonday – Friday, standard business hours with flexibility as needed to meet project milestonesFrequent interaction with machinery, tools, and production materialsREPORTING STRUCTURE:
This position will report to the Quality Manager.
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