Quality Manager - Medical Devices

Martech Medical Products, Inc.; Harleysville (PA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

401(k) Retirement Plan

Job summary

Martech Medical Products seeks a Quality Manager to lead Quality Engineering and Quality Control, guiding the QMS to meet FDA and ISO standards and drive continuous improvement. You will influence manufacturing excellence, regulatory compliance, and operational performance across the site.

The role requires 8+ years in quality with leadership experience, strong regulatory knowledge, and a passion for building high-performing teams in a regulated manufacturing setting.

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, Life Sciences, or a related technical discipline.
• 8+ years in Quality Assurance/Engineering/Systems within regulated manufacturing (medical devices).
• 3+ years in leadership managing quality or technical teams.
• Strong knowledge of FDA QMSR/21 CFR Part 820 and ISO 13485.
• Experience leading CAPA, audits, nonconformance programs, risk mgmt, and CI.
• Analytical, problem-solving, communication, and leadership skills.

Responsibilities

• Lead Quality Engineering and Quality Control to meet quality, compliance, and ops goals.
• Maintain and improve QMS per FDA QMSR, ISO 13485, and regulatory requirements.
• Drive CAPA, audits, nonconformance, investigations, and change control.
• Lead risk management and promote risk-based decision making.
• Collaborate with Manufacturing and Engineering on validations and qualifications.
• Monitor quality metrics and drive continuous improvement initiatives.
• Support cleanroom operations and audit readiness.
• Lead root cause investigations and corrective/preventive actions.
• Represent quality in customer, certification body, and regulatory audits.
• Develop and mentor a high-performing quality team.

Skills

Quality Leadership

Regulatory Knowledge

QMS & ISO 13485

FDA QMSR (21 CFR Part 820)

CAPA & Audits

Risk Management

Data-driven Decision Making

Leadership

Process Validation

Education

Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related

ASQ CQE or CQA certification

Tools

Minitab

JMP

Job description

Quality Manager

Full-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.

Lead Quality. Drive Excellence. Impact Patient Care.

At Martech Medical Products, quality is more than compliance. It's a commitment to the patients who depend on the medical devices our customers bring to market.

We're looking for an experienced Quality Manager to lead our Quality Engineering and Quality Control teams and help shape the future of our quality organization. This is a high-impact leadership role where you'll influence manufacturing excellence, regulatory compliance, operational performance, and continuous improvement across the facility.

If you're passionate about building strong teams, driving process improvements, and creating a culture where quality is everyone's responsibility, we'd love to hear from you.

What You’ll Do

As 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 Like

• 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 For

Required 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 challengesHelp ensure the manufacture of products that support patient care worldwide

Benefits & Perks

Martech 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.

Martech Medical Products is an Equal Opportunity Employer and is committed to creating an inclusive workplace for all employees. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.