Top 7 Quality manager medical devices Jobs in Pottstown, Pa

Quality Manager - Medical Devices
Martech Medical Products —Harleysville, PA
- Full-time
- Engineering
- 3 years
- Analysis skills
- Paid holidays
- Health insurance
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Director, Quality
Globus Medical —Audubon, PA
- Full-time
- 5 years
- Computer literacy
- Bachelor of Science
Director, Quality (External Manufacturing)
Paratek Pharmaceuticals —King of Prussia, PA
- Hybrid work
- 11+ years
- Bachelor's degree
- Travel
7h
Quality Control Manager - Precision Machining
Acero Precision —West Chester, PA
- $35 - $45 an hour
- Overtime
- Management
- 5 years
- Engineering
- Paid training
- Health savings account
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Quality & Compliance Manager
Peregrine Surgical LTD —Doylestown, PA
- Full-time
- Surgery
- 5 years
- English
- AD&D insurance
- Paid holidays
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11d
Senior Manager SAP QM, Functional Design & Architect
West Pharmaceutical Services —Exton, PA
- Hybrid work
- Background check
- Computer Science
- Analysis skills
14d
Director, Manufacturing Quality, GIS (Japan Based)
Olympus —Center Valley, PA
- $134,666 - $188,532 a year
- Full-time
- Remote
- Analysis skills
- Bachelor's degree
- Travel
- Paid parental leave
- Paid holidays

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quality manager medical devices jobs near pottstown, pa

Quality Manager - Medical Devices

Martech Medical Products -
Harleysville, PA

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Job Details

Full-time

Benefits

Paid holidays
Health insurance
Dental insurance
Flexible spending account
Paid time off
Vision insurance
401(k) matching
Opportunities for advancement
Life insurance
Prescription drug insurance

Qualifications

ISO standards
Preventive action implementation
Production deviation management
Corrective and preventive actions (CAPA)
Quality control audit
Manufacturing facility experience
Managing engineering teams
Quality risk management
Medical device manufacturing facility experience
Leading team collaboration initiatives
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Managing product quality assurance teams
Quality improvement programs in engineering
Legal compliance
FDA regulations
Audit support

Full 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
In 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 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 challenges
✅ Help 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.

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quality manager medical devices jobs in pottstown, pa

Quality Manager - Medical Devices

Director, Quality

Director, Quality (External Manufacturing)

Quality Control Manager - Precision Machining

Quality & Compliance Manager

Senior Manager SAP QM, Functional Design & Architect

Director, Manufacturing Quality, GIS (Japan Based)

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