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Medical Device Qa Jobs (NOW HIRING)

Biogen

Senior Device Quality Engineering Lead

Cambridge, MA · On-site

$138K - $185K/yr

Manage quality assurance interfaces with medical device suppliers and testing partners in collaboration with External Quality. Who You Are: You are a detail-oriented and dedicated professional with a ...

A-dec, Inc.

Quality Assurance Specialist, Sr

Newberg, OR · Remote

$86K - $119K/yr

... Medical Device regulations and standards including US-FDA, Health Canada, and the European Union ... Coaches and mentors Quality Assurance Specialist(s) to grow capabilities and technical acumen.

A-dec, Inc.

Quality Assurance Specialist, Sr

Newberg, OR · On-site

$86K - $119K/yr

... Medical Device regulations and standards including US-FDA, Health Canada, and the European Union ... Coaches and mentors Quality Assurance Specialist(s) to grow capabilities and technical acumen.

Marquee Staffing - OC

Be Seen First

Medical Device Assembler, 4/10 Schedule 1st or 2nd Shift

Irvine, CA · On-site

$19 - $21.50/hr

Medical Device implant manufacturer in Irvine is seeking applicants with manufacturing experience ... quality assurance program, as well as safety and environmental standards. Ability to establish ...

Applied Medical

Quality Inspector

Lake Forest, CA · On-site

$18/hr

... for medical device manufacturing and quality assurance. Key Responsibilities * Perform First Article and Final inspections using measuring tools and equipment such as pin gauges, calipers ...

Applied Medical

Quality Inspector

Lake Forest, CA

$18 - $23/hr

... for medical device manufacturing and quality assurance. Key Responsibilities * Perform First Article and Final inspections using measuring tools and equipment such as pin gauges, calipers ...

Applied Medical

Quality Inspector

Lake Forest, CA · On-site

$18 - $23/hr

... for medical device manufacturing and quality assurance. Key Responsibilities * Perform First Article and Final inspections using measuring tools and equipment such as pin gauges, calipers ...

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Medical Device QA information

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$12

$36

$70

How much do medical device qa jobs pay per hour?

As of Aug 12, 2026, the average hourly pay for medical device qa in the United States is $36.79, according to ZipRecruiter salary data. Most workers in this role earn between $18.27 and $50.00 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a medical device QA, and why are they important?

To thrive as a Medical Device QA, you need a solid understanding of quality assurance principles, regulatory standards (such as ISO 13485 and FDA 21 CFR Part 820), and a relevant degree in engineering or life sciences. Familiarity with quality management systems (QMS), document control software, and auditing tools is typically required, along with certifications like Certified Quality Auditor (CQA) or Six Sigma. Strong attention to detail, problem-solving abilities, and effective communication help ensure compliance and drive continuous improvement. These skills and qualities are crucial to maintaining product safety, regulatory compliance, and overall quality within the highly regulated medical device industry.

What are some common challenges faced by medical device QA professionals, and how can they be addressed?

Medical Device QA professionals often encounter challenges such as navigating complex regulatory requirements, ensuring product consistency, and keeping up with frequent changes in standards. Addressing these challenges typically involves staying current with FDA and ISO updates, maintaining robust documentation practices, and fostering clear communication with cross-functional teams like R&D and manufacturing. Regular training sessions and proactive risk management strategies also help QA professionals ensure quality and compliance throughout the product lifecycle.

What is a medical device QA?

Medical Device Quality Assurance (QA) professionals are responsible for ensuring that medical devices meet regulatory standards and are safe and effective for use. They develop and implement quality management systems, conduct audits, and oversee documentation throughout the product lifecycle. QA professionals also work closely with engineering, manufacturing, and regulatory teams to identify and resolve quality issues, manage risk, and ensure compliance with industry standards such as ISO 13485 and FDA regulations.

What is the difference between Medical Device Qa vs Medical Device Quality Inspector?

AspectMedical Device QaMedical Device Quality Inspector
CertificationsISO 13485, FDA regulations, Six SigmaISO 13485, FDA regulations, Six Sigma
Work EnvironmentDesign, development, and process oversight in manufacturingInspection and testing on production lines
ResponsibilitiesEnsuring quality systems and complianceInspecting products for defects and conformance

Medical Device Qa professionals focus on quality assurance processes, compliance, and system improvements, while Medical Device Quality Inspectors primarily perform product inspections and defect detection. Both roles require similar certifications and work within the medical device industry, but their daily tasks and focus areas differ significantly.

More about Medical Device QA jobs
What cities are hiring for Medical Device Qa jobs? Cities with the most Medical Device Qa job openings:
What states have the most Medical Device Qa jobs? States with the most job openings for Medical Device Qa jobs include:
What job categories do people searching Medical Device Qa jobs look for? The top searched job categories for Medical Device Qa jobs are:
Medical Device QA jobs near you
Infographic showing various Medical Device Qa job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $76,520 per year, or $36.8 per hour.

Distribution Quality Assurance Specialist

Hologic

Newark, DE • On-site

$65K - $103K/yr

Full-time

Re-posted 6 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

175th of 487 rated machine equipment manufacturers

Job description


The Distribution Quality Assurance Specialist at Hologic is responsible for ensuring the quality and compliance of distribution processes, particularly through the assessment, qualification, and ongoing management of Distribution Service Providers (DSPs) such as 3PLs, Logistic Service Providers, and Distributors.
The role focuses on maintaining product integrity throughout distribution channels, supporting continuous improvement, and ensuring alignment with U.S. FDA regulations, ISO standards, and internal quality system requirements. The position requires collaboration with various departments, oversight of compliance documentation, and active participation in audits, risk management, and corrective actions.
Knowledge
  • Proficient understanding of U.S. FDA regulations (21 CFR Parts 11 and 820), ISO 13485, and medical device quality systems
  • Experience in root cause analysis, risk assessment, CAPA (Corrective and Preventive Actions), and auditing
  • Knowledge of logistics and distribution processes
  • Familiarity with PLM and ERP systems
  • Computer literacy, including Microsoft Office; knowledge of Power BI and AI tools is a plus

Skills
  • Strong analytical and problem-solving abilities
  • Ability to produce reports and define action plans
  • Excellent interpersonal and cross-functional communication skills
  • Negotiation and persuasion skills
  • Adaptability to changing environments
  • Ability to work independently and collaboratively
  • Proactive and organized, with the capacity to manage multiple priorities and meet deadlines

Behavior
  • Demonstrates ownership and accountability
  • Acts with integrity and a quality mindset
  • Drives continuous improvement
  • Maintains a customer-focused approach
  • Works effectively both individually and in teams

Experience
  • Bachelor's Degree in Engineering, Quality Assurance, Supply Chain Management, Logistics, or a related field (advanced degree is a plus)
  • Minimum of 3 years' experience in medical device manufacturing or a related industry, preferably within a Quality function
  • Experience supporting FDA inspections and internal/external audits
  • Experience with logistics and distribution processes is highly preferred

Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $65,900 - $103,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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