Quality ManagerFull-Time | Onsite*This position is not eligible for relocation assistance or employer-sponsored work authorization. Candidates must be legally authorized to work in the United States and not require sponsorship now or in the future.What You'll DoAs Quality Manager, you'll serve as a key member of the site leadership team and be responsible for the overall effectiveness of our Quality Management System while ensuring compliance with FDA and international quality standards.
Key Responsibilities- Lead Quality Engineering and Quality Control teams to achieve quality, compliance, and operational objectives.
- Maintain and continuously improve the Quality Management System (QMS) in accordance with FDA QMSR (21 CFR Part 820), ISO 13485, ISO 14971, and applicable regulatory requirements.
- Drive quality system initiatives, including CAPA, internal audits, nonconformance management, complaint investigations, and change control activities.
- Lead risk management efforts and promote risk-based decision making across manufacturing and business processes.
- Partner with Manufacturing and Engineering to support process validations, equipment qualifications, automation initiatives, and new product introductions.
- Monitor quality metrics and implement continuous improvement initiatives that improve performance, reduce risk, and enhance customer satisfaction.
- Support cleanroom manufacturing operations, contamination control programs, and ongoing audit readiness.
- Lead root cause investigations and implement effective corrective and preventive actions.
- Serve as the primary quality representative during customer, certification body, and regulatory audits.
- Develop, coach, and mentor a high-performing quality team while fostering a culture of accountability, collaboration, and continuous improvement.
- Collaborate with Operations, Engineering, Supply Chain, and Regulatory Affairs to ensure product quality, regulatory compliance, and operational effectiveness.
What Success Looks LikeIn this role, you'll:
- Build and develop a strong, engaged quality team.
- Ensure sustained compliance and audit readiness.
- Strengthen quality systems and risk management processes.
- Improve operational performance through data-driven decision making.
- Partner cross-functionally to solve complex manufacturing and quality challenges.
- Create a culture where quality is embedded in every process and decision.
What We're Looking ForRequired Qualifications- Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or a related technical discipline.
- 8+ years of progressive experience in Quality Assurance, Quality Engineering, or Quality Systems within the medical device industry or another highly regulated manufacturing environment.
- 3+ years of leadership experience managing quality or technical teams.
- Strong knowledge of FDA Quality System Regulations (QMSR/21 CFR Part 820), ISO 13485, and quality system requirements.
- Experience leading CAPA, audits, nonconformance programs, risk management activities, and continuous improvement initiatives.
- Strong analytical, problem-solving, communication, and leadership skills.
Preferred Qualifications- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar certification.
- Lean Six Sigma Green Belt or Black Belt certification.
- Experience with ISO 14971 risk management methodologies.
- Experience supporting Class I, II, and/or III medical devices.
- Experience with process validation, SPC, MSA, and statistical analysis tools such as Minitab or JMP.
- Experience with supplier quality management and audit programs.
Why Join Martech Medical Products?This is an opportunity to take ownership of a critical leadership function within a growing medical device manufacturing organization.
You'll have the chance to:
• Lead and develop a talented quality team
• Drive strategic quality initiatives and continuous improvement efforts
• Influence business decisions at the leadership level
• Partner with cross-functional teams to solve meaningful challenges
• Help ensure the manufacture of products that support patient care worldwide
Benefits & PerksMartech Medical Products offers a competitive compensation and benefits package designed to support the health, financial well-being, and work-life balance of our employees, including:
- Medical Insurance
- Dental Insurance
- Prescription Drug Coverage
- Vision Insurance
- Flexible Spending Accounts (FSA)
- Company-Paid Life Insurance
- 401(k) Retirement Plan with Generous Company Match
- Paid Holidays
- Paid Time Off (PTO)
- Professional Development and Career Growth Opportunities
If you're a collaborative leader who thrives in a fast-paced, regulated environment and is passionate about quality excellence, we encourage you to apply.
