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Medical Device Quality Assurance Jobs (NOW HIRING)

Kellton Tech

Medical Device Quality Inspector

Madison, WI · On-site

$25 - $30/hr

Medical Device Quality Inspector Location: Madison, WI (Onsite) Pay Rate: $25-30/hr. on W2 **Opportunity to earn overtime pay** The Medical Device Quality Inspection group is responsible for assuring ...

6AM City

QA Specialist

Columbia, SC

$80K - $115K/yr

This is a growing medical device company with offices in the US, Europe, and Australia, that has been in business for over 20 years. They are looking for a QA Specialist who will work with their ...

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

Bachelor's degree (or higher) in a science or technology field preferred * 5+ years of Quality Assurance experience in a cGMP-regulated environment (medical device experience preferred) Skills ...

Ketryx

QA/RA Consultant

Boston, MA · On-site +1

$130K - $150K/yr

Job Title: QA/RA Consultant Employment Status: Full-time Office Hours: Monday - Friday; hybrid ... About You: You're a proven QMS expert who's successfully navigated complex medical device ...

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Medical Device Quality Assurance information

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$12

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How much do medical device quality assurance jobs pay per hour?

As of Jul 27, 2026, the average hourly pay for medical device quality assurance in the United States is $29.29, according to ZipRecruiter salary data. Most workers in this role earn between $18.75 and $34.38 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Medical Device Quality Assurance position, and why are they important?

To thrive as a Medical Device Quality Assurance professional, you need a strong background in quality systems, regulatory compliance, and risk management, often supported by a science or engineering degree and relevant work experience. Familiarity with ISO 13485, FDA 21 CFR Part 820, CAPA systems, and quality management software is typically required, along with certifications such as ASQ Certified Quality Auditor (CQA) being advantageous. Exceptional attention to detail, strong analytical thinking, and effective communication help distinguish top performers in this field. Mastery of these skills and tools ensures that medical devices consistently meet strict regulatory standards, supporting patient safety and organizational reputation.

What is a Medical Device Quality Assurance job?

A Medical Device Quality Assurance (QA) job ensures that medical devices meet regulatory standards, quality requirements, and safety guidelines before they reach the market. QA professionals develop and implement quality systems, conduct audits, review documentation, and collaborate with regulatory bodies to maintain compliance with standards like ISO 13485 and FDA regulations. Their role is crucial in preventing defects, ensuring patient safety, and improving product reliability.

What are the typical daily responsibilities of someone working in Medical Device Quality Assurance?

Professionals in Medical Device Quality Assurance typically review and update quality management systems, conduct internal audits, oversee corrective and preventive action (CAPA) processes, and collaborate closely with product development and manufacturing teams to ensure regulatory compliance. They are often involved in the review of documentation, facilitation of risk assessments, and addressing nonconformances that arise during production or post-market surveillance. Daily work may also include preparing for and participating in regulatory inspections, training staff on quality procedures, and maintaining up-to-date knowledge of relevant standards. This role is both detail-oriented and collaborative, playing a vital part in ensuring product quality and regulatory adherence.

More about Medical Device Quality Assurance jobs
What cities are hiring for Medical Device Quality Assurance jobs? Cities with the most Medical Device Quality Assurance job openings:
What are the most commonly searched types of Medical Device Quality Assurance jobs? The most popular types of Medical Device Quality Assurance jobs are:
What states have the most Medical Device Quality Assurance jobs? States with the most job openings for Medical Device Quality Assurance jobs include:
What job categories do people searching Medical Device Quality Assurance jobs look for? The top searched job categories for Medical Device Quality Assurance jobs are:
Medical Device Quality Assurance jobs near you
Infographic showing various Medical Device Quality Assurance job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 90% Full Time, 7% Part Time, and 2% Contract. Highlights an 93% Physical, 3% Hybrid, and 4% Remote job distribution, with an average salary of $60,925 per year, or $29.3 per hour.
Sr. Manager, Medical Device Quality Assurance

Sr. Manager, Medical Device Quality Assurance

Regeneron Pharmaceuticals

Valley, AL • On-site

$126K - $206K/yr

Part-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 17 days ago

Regeneron rating

8.7

Company rating: 8.7 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

14th of 86 rated pharmaceutical

Job description

Build our future together:

Regeneron is currently seeking a Senior Manager, Medical Device Quality Assurance (QA) to join our Medical Device QA team. This expanded leadership role will provide QA oversight across two critical functions: Combination Products Sustaining Engineering and Compliance. The position will lead a team of engineers and quality specialists.

When & where:

  • Location: East Greenbush, New York, United States
  • Work model: Monday-Friday, 8am-4:30pm

What you'll do:

  • Manage, mentor, and develop quality engineering and compliance teams
  • Standardize, streamline, and improve processes across sustaining and compliance
  • Implement digital, data-driven tools for accurate, consistent, and timely reporting
  • Lead teams through complex, ambiguous challenges in a pharmaceutical/medical device environment
  • Sustaining Engineering Support:
    • Support sustaining engineering programs through risk assessment, design change management, and maintenance of the Design History File and Risk Management File
    • Advice and actively participate in Design Reviews associated with combination products
    • Provide QA and technical support to quality engineers and project teams during ongoing maintenance of the combination product
    • Interact with partners and contract organizations to ensure accurate completion of project milestones, including post-commercialization activities
  • Combination Product Support:
    • Act as Management Representative for the combination products QMS; own policies and procedures
    • Support regulatory inspections and partner audits for combination products
    • Keep the QMS current and inspection-ready via monitoring, gap assessments, and updates

This role requires:

  • BS in Engineering and 8+ years of experience; including combination product or medical device experience; or equivalent combination of education & experience
  • Previous supervisory/ people leadership experience
  • Knowledge of the combination device development and lifecycle process

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.


Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.


As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.


For jobs in Canada: this posting is for an existing position.


Salary Range (annually)

$126,300.00 - $206,100.00

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