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Medical Device Design Quality Assurance Engineer Jobs

Qnovia, Inc.

Quality Assurance Engineer

Newport Beach, CA · On-site

$110K - $145K/yr

Review and approve device master records, batch records, and engineering change orders * Manage ... Background in design control for Class II or Class III medical devices * Experience with process ...

Ambu

Quality Engineer

Noblesville, IN · On-site

$67K - $87K/yr

Quality Assurance Department: QA, Noblesville Employment Type: Full-time Req ID: 9887 We are seeking a Quality Engineer with experience in medical device design quality and risk management to support ...

Hanger

QA/QC Engineer I

Phoenix, AZ · On-site

$71K - $92K/yr

The QA Engineer I also works with Product Development by completing required design control ... Some experience in the medical device industry, quality assurance, regulatory affairs, or a related ...

Data Device Corporation

QA Engineer

Bohemia, NY · On-site

$70K - $105K/yr

For more than 60 years, DDC has been recognized as a world leader in the design and manufacture of ... Data Device Corporation is an Affirmative Action/Equal Opportunity Employer and is committed to ...

Hanger, Inc.

QA/QC Engineer I

Phoenix, AZ · On-site

The QA Engineer I also works with Product Development by completing required design control ... Some experience in the medical device industry, quality assurance, regulatory affairs, or a related ...

Hanger, Inc.

QA/QC Engineer I

Phoenix, AZ · On-site

The QA Engineer I also works with Product Development by completing required design control ... Some experience in the medical device industry, quality assurance, regulatory affairs, or a related ...

United Employment Group

Be Seen First

Quality Assurance Engineer

Memphis, TN · On-site

$90K - $110K/yr

Associate's degree or equivalent from an accredited two-year college/technical school, or higher will be considered, plus 2-4 years of quality assurance engineering experience in a medical device ...

Katalyst CRO

QA Engineer

Warrendale, PA · On-site

Responsibilities : • Perform test planning, test case design, and test execution. • Conduct ... and medical device companies worldwide. Founded in , the company is headquartered in South ...

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Medical Device Design Quality Assurance Engineer information

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

As of Sep 10, 2026, the average hourly pay for medical device design quality assurance engineer in the United States is $48.54, according to ZipRecruiter salary data. Most workers in this role earn between $38.22 and $55.53 per hour, depending on experience, location, and employer.

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

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

Infographic showing various Medical Device Design Quality Assurance Engineer job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 79% Full Time, 15% Part Time, and 5% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $100,970 per year, or $48.5 per hour.

Quality Assurance Engineer

Newport Beach, CA • On-site

Qnovia, Inc.
1 - 10 employees
Learn more about Qnovia, Inc.external

$110K - $145K/yr

Other

Medical, Dental, Vision, Retirement

Posted 23 days ago

Job description

Develop and maintain quality management systems and ensure regulatory compliance across Qnovia's product development and manufacturing operations.

About the Role

Qnovia operates under a quality management system designed to meet FDA 21 CFR 820 and ISO 13485 requirements. As a Quality Assurance Engineer, you will be responsible for maintaining and continuously improving our QMS, supporting design control activities, and ensuring that all products meet established quality standards. This role is essential to our ability to advance products through regulatory approval and into commercial production.

Responsibilities
  • Maintain and improve the Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR 820
  • Support design control activities including design reviews, risk analysis, and design transfer
  • Conduct internal audits and manage CAPA (Corrective and Preventive Action) processes
  • Review and approve device master records, batch records, and engineering change orders
  • Manage supplier qualification and incoming inspection programs
  • Support regulatory inspections and external audits
  • Develop and maintain quality metrics and management review reporting
  • Investigate product complaints and nonconformances; drive root cause analysis and corrective actions
Qualifications
  • Bachelor's degree in engineering, life sciences, or related field
  • 5+ years of quality assurance experience in medical device or pharmaceutical manufacturing
  • In-depth knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971
  • Experience with CAPA, NCR, and complaint handling systems
  • Strong analytical and problem‑solving skills
  • Experience with electronic QMS platforms (MasterControl, Greenlight Guru, or equivalent)
Preferred Qualifications
  • Experience with combination product quality requirements
  • Background in design control for Class II or Class III medical devices
  • Experience with process validation (IQ/OQ/PQ) protocols

$110,000 – $145,000 annually, depending on experience. Equity participation included.

  • Comprehensive medical, dental, and vision insurance
  • Equity ownership in a pre‑commercial stage company
  • Flexible hybrid work arrangement
  • 401(k) with company match

Qnovia, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by applicable federal, state, or local law.

If you require a reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please contact us at careers@qnovia.com.

This job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Qnovia reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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