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Medical Device Quality Engineer Resume Jobs (NOW HIRING)

Amphenol Alden Products

Quality Engineer

Stoughton, MA · On-site

$75K - $85K/yr

The medical device quality engineer supports the development, manufacture, and ongoing compliance of medical devices with a regulated quality management system. This role is responsible for ensuring ...

HotRun Inc.

Quality Engineer

Longview, TX · On-site

$64K - $82K/yr

... medical device expectations and goals. § Formulate and maintain accurate documentation to meet all quality system and medical device expectations. § Lead and manage direct and indirect reports ...

HotRun Inc.

Quality Engineer

Longview, TX · On-site

$90K - $115K/yr

... medical device expectations and goals. § Formulate and maintain accurate documentation to meet all quality system and medical device expectations. § Lead and manage direct and indirect reports ...

HotRun Inc.

Quality Engineer

Longview, TX

$64K - $82K/yr

Are you and experienced quality engineer who would like to work for a global supplier of medical ... Ensure the quality management system meets the company's medical device expectations and goals.

Jobtailor

Senior Design Quality Engineer

Irvine, CA · On-site

$95K - $128K/yr

Highest-signal resume keywords * Quality Engineering Leadership * Statistical Analysis * Risk Management Methodologies * Design of Experiments (DOE) * Medical Device Quality Systems ATS Optimization ...

Caraballo Consulting & Associates L

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QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

We are seeking a Quality Manufacturing Engineer extensive experience in Medical Devices to oversee Manufacturing Quality projects and line transfers for a Medical Device company. The perfect ...

Caraballo Consulting & Associates L

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QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

We are seeking a Quality Manufacturing Engineer extensive experience in Medical Devices to oversee Manufacturing Quality projects and line transfers for a Medical Device company. The perfect ...

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Medical Device Quality Engineer Resume information

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How much do medical device quality engineer resume jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for medical device quality engineer resume in the United States is $36.72, according to ZipRecruiter salary data. Most workers in this role earn between $24.76 and $45.91 per hour, depending on experience, location, and employer.

What is a medical device quality engineer?

A Medical Device Quality Engineer resume is a document that outlines your experience, skills, and qualifications specific to quality engineering roles within the medical device industry. It typically highlights your knowledge of regulatory standards (like FDA or ISO 13485), experience with quality assurance processes, risk management, and validation techniques. Employers look for resumes that demonstrate your ability to ensure product safety, compliance, and continuous improvement. A strong resume will also showcase your problem-solving abilities and any relevant certifications or technical proficiencies.

What are the key skills and qualifications needed to thrive as a medical device quality engineer?

To thrive as a Medical Device Quality Engineer, you need a solid background in engineering, knowledge of quality assurance principles, and familiarity with regulatory standards such as ISO 13485 and FDA 21 CFR Part 820. Proficiency with quality management systems (QMS), risk analysis tools like FMEA, and software for document control is typically required, and certifications such as CQE (Certified Quality Engineer) are highly valued. Strong attention to detail, problem-solving abilities, and effective communication skills help you collaborate across teams and ensure compliance. These skills and qualities are vital for maintaining product safety, ensuring regulatory compliance, and supporting successful product development in the medical device industry.

What are some common challenges medical device quality engineers face when balancing regulatory compliance with project timelines?

Medical Device Quality Engineers often encounter the challenge of ensuring strict regulatory compliance while meeting demanding project deadlines. Navigating evolving FDA and ISO standards, coordinating with cross-functional teams, and managing documentation can create time pressures. Effective communication and proactive planning help mitigate delays, but unanticipated non-conformities or audits can still impact schedules. Being adaptable and detail-oriented is key to successfully balancing compliance and timely product delivery.

What are popular job titles related to Medical Device Quality Engineer Resume jobs?

For Medical Device Quality Engineer Resume jobs, the most frequently searched job titles are:

Quality Engineer

Stoughton, MA • On-site

Amphenol Alden Products
Electrical Equipment, Appliance, and Component Manufacturing • 201 - 500 employees
Learn more about Amphenol Alden Productsexternal

$75K - $85K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 22 days ago

Job description

Join Amphenol Alden and Make a Difference in Patient Care Worldwide!
At Amphenol Alden, we're dedicated to providing critical support to patients globally. Every device we manufacture directly impacts someone's loved one, a responsibility we hold with utmost seriousness. With roots as a family business over 80 years ago, we maintain a dynamic, entrepreneurial spirit, even now as part of a global corporation.
We recognize that our employees are at the cornerstone of our future, and we prioritize exceptional benefits, competitive compensation, work/life balance, and career development.
Due to our continuous expansion, we're seeking talented individuals to strengthen our team. We currently have an exciting opportunity for a Quality Engineer at our new Stoughton MA facility.
Job Summary: The medical device quality engineer supports the development, manufacture, and ongoing compliance of medical devices with a regulated quality management system. This role is responsible for ensuring products and processes meet applicable regulatory requirements, internal quality standards, and customer expectations.
Primary Duties and Responsibilities:
• Work with engineering to develop inspection planning and documentation packages for customers.
• Work with customers regarding nonconformance, quality alerts and CAPA (problem solve).
• Execute First Article Inspections (FAI), CPK Studies, and GR&R
Skills/Qualifications Needed:
• Experience as a Quality Engineer in a manufacturing environment.
• Knowledge of ISO1348:16 and 21 CFR Part 820 Medical Device Requirements.
• Knowledge of PFMEA, Process Control Plans, Process Maps, other Engineering and Quality related processes.
• Knowledge of Validation (IQ, OQ, PQ)
• Computer skills: Word, Excel, PowerPoint, Minitab, etc.
• 4-Year College Degree; preferably in engineering or related.
• Ability to travel globally as needed to other AAP, supplier, and customer locations.
• Minimum 5 years' related experience in a manufacturing environment.
• Ability to travel as needed to other AAP, supplier, and customer locations.
Desired Skills:
• Lead auditor training to ISO13485:16 or ISO9001:15.
• Highly organized with excellent verbal and written skills, self-motivated.
• Understanding of REACH, ROHS, and Conflict Materials.
What We Offer:
• An opportunity to join a growing team dedicated to making a difference.
• Competitive salary, bonuses, and comprehensive benefits program, including medical, dental, vision, short and long-term disability, 401(K), PTO, HSA, FSA, employee discounts, life insurance, and employee activities.
Amphenol Alden Products is an Equal Opportunity Employer
Applicants must be legally authorized to work in the US without current or future employer sponsorship.

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