Director of Quality

Job Description

Job Description

Employment Type: 1st Shift, Full-time, direct hire

Job Brief
Kable Workforce Solutions is hiring a Director of Quality for our client. The role will be responsible for an established manufacturer. This leader owns the Quality Management System (QMS) for the medical device business and keeps the site compliant with FDA 21 CFR Part 820 (QMSR, incorporating ISO 13485:2016), ISO 14971 and other applicable FDA and international requirements.

What’s a Typical Day Like?

• Develop, maintain, and scale the QMS to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and applicable international regulations.
• Lead internal, customer, and third-party regulatory audits, including FDA and ISO certification audits, and maintain site audit readiness.
• Oversee Corrective and Preventive Actions (CAPA), Nonconformance Reports (NCRs), and Material Review Board (MRB) activities.
• Manage customer complaints, product quality investigations, and Medical Device Reporting (MDR) obligations.
• Manage the supplier quality program, including vendor evaluations, qualification audits, and incoming material controls.
• Review and approve engineering changes, process validations, pFMEAs, and final product specifications.
• Ensure data integrity and validation of computerized systems, including eQMS, ERP, and production software, under FDA 21 CFR Part 11 and EudraLex Annex 11.
• Mentor, train, and manage Quality Control and Quality Assurance staff.
• Partner with R&D and Engineering on Design Controls from concept through commercialization.
• Track and report Quality Objectives and KPIs to senior leadership.
• Support FDA 510(k), PMA, and CE Mark submissions.

What Are the Requirements of the Job?

• Bachelor’s degree in Science, Engineering, or a related technical field.
• 5+ years of experience in Quality Assurance, Quality Control, or Quality Engineering in an FDA-regulated environment; medical device manufacturing preferred.
• 2–3+ years of direct experience managing quality teams, supervisors, or engineers.
• Hands-on experience hosting and managing FDA, ISO, or EU notified body audits.
• Working knowledge of 21 CFR Part 820, ISO 13485:2016, ISO 14971, 21 CFR Part 11, and EudraLex Annex 11.
• 3+ years of experience with Medical Device Reporting (21 CFR 803), corrections and removals (21 CFR 806), and Unique Device Identification (UDI) (21 CFR 830).
• Experience with EU MDR, CAPA systems, FMEA, IQ/OQ/PQ validation, and statistical process control.
• ISO 13485 Lead Auditor or Internal Auditor certification.
• ASQ certification (CQE, CQA, CBA, or CMQ/OE) preferred.
• Strong leadership, communication, project management, and problem-solving skills.
• Proficiency in Microsoft Office.
• Ability to occasionally lift 5–20 lbs, reach overhead, and crouch.
• Ability to walk, stand, or sit for up to 95% of the workday.
• Ability to work in environments ranging from 50–85&degree;F.
• Ability to wear required PPE, including smock/suit, shoe covers, dust mask, and safety glasses.

How to Apply  And Next Steps?
Please submit your resume in our application by clicking “apply now.” We look forward to reviewing your application and you will hear from us within 1 business day.

About Kable Workforce Solutions
For over 50 years, Kable Workforce Solutions   has been connecting skilled professionals with leading employers across the region. We’re dedicated to helping people build lasting careers and helping companies grow through quality, integrity, and partnership.

We believe in people first — empowering individuals to succeed and celebrating the work that drives our communities forward.

Kable Workforce Solutions   is proud to be an equal opportunity employer. We welcome and value diversity and are committed to creating an inclusive workplace where everyone can thrive. Read our full diversity statement here.

This job description is not intended to be all-inclusive, and the employee will also perform other reasonably related business duties as assigned by the immediate supervisor and other management as required.