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Senior Quality Engineer Medical Device Jobs (NOW HIRING)

Tempus AI

Senior Quality Engineer

Redwood City, CA · On-site

$108K - $146K/yr

As a Senior Quality Engineer, you will lead verification, validation, and maintenance of systems ... Medical Device(s). • Develop and maintain CSV policies, procedures, templates and work ...

Stryker

Senior Quality Engineer (Onsite)

Ventura, CA · On-site

$85K - $142K/yr

Onsite Stryker is hiring a Senior Quality Engineer for our TMJ portfolio located in Ventura ... Minimum 3 years of experience in medical device manufacturing or quality engineering. * Master ...

Stryker

Senior Quality Engineer (Onsite)

Ventura, CA · On-site

$85K - $142K/yr

Onsite Stryker is hiring a Senior Quality Engineer for ourTMJ portfoliolocated in Ventura ... Minimum 3 years of experience in medical device manufacturing or quality engineering. * Master ...

Nova Biomedical

Senior Quality Engineer

Billerica, MA · On-site

$94K - $127K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

The Senior Quality Engineer will provide Quality Engineering support to ensure that quality ... ASQ Certification as Medical Device Auditor is a plus. * ASQ Certification as Quality Engineer is ...

Nova Biomedical

Senior Quality Engineer

Billerica, MA

$94K - $127K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

The Senior Quality Engineer will provide Quality Engineering support to ensure that quality ... ASQ Certification as Medical Device Auditor is a plus. * ASQ Certification as Quality Engineer is ...

Flotec

Be Seen First

Quality Engineer

Avon, IN · On-site

$70K - $90K/yr

  • Medical

  • Dental

  • Vision

Quality Engineer - Medical Device Manufacturing Company Overview Flotec is an Indianapolis-based medical device manufacturer specializing in respiratory and oxygen delivery equipment. We manufacture ...

Nova Biomedical

Senior Quality Engineer

Billerica, MA · On-site

$94K - $127K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

The Senior Quality Engineer will provide Quality Engineering support to ensure that quality ... ASQ Certification as Medical Device Auditor is a plus. * ASQ Certification as Quality Engineer is ...

Tactile Medical

Senior Quality Engineer

Minneapolis, MN

$92K - $125K/yr

The Senior Quality Engineer provides quality engineering leadership for manufacturing and ... medical device industry * Bachelor level degree in Engineering (Mechanical, Material Science or ...

Osv_bioventus

Sr Quality Engineer

Memphis, TN

$86K - $116K/yr

The Sr Quality Engineer provides quality engineering expertise to manufacturing, engineering ... Ensure medical device regulatory requirements (21 CFR 820, EU MDD/MDR, ISO 13485:2016 and IEC 60601 ...

Osv_bioventus

Sr Quality Engineer

Memphis, TN

$86K - $116K/yr

The Sr Quality Engineer provides quality engineering expertise to manufacturing, engineering ... Ensure medical device regulatory requirements (21 CFR 820, EU MDD/MDR, ISO 13485:2016 and IEC 60601 ...

Nova Biomedical

Senior Quality Engineer

Norwood, MA

$100K - $135K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Bachelor's degree or higher in Engineering or the technical sciences * 7 plus years Medical Device/IVD Experience as a Quality Engineer, or 4+ as a Senior Quality Engineer within an FDA regulated ...

Nova Biomedical

Senior Quality Engineer

Norwood, MA

$100K - $135K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Bachelor's degree or higher in Engineering or the technical sciences * 7 plus years Medical Device/IVD Experience as a Quality Engineer, or 4+ as a Senior Quality Engineer within an FDA regulated ...

Nova Biomedical

Senior Quality Engineer

Norwood, MA · On-site

$100K - $135K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Bachelor's degree or higher in Engineering or the technical sciences * 7 plus years Medical Device/IVD Experience as a Quality Engineer, or 4+ as a Senior Quality Engineer within an FDA regulated ...

Bioventus

Sr Quality Engineer

Memphis, TN · On-site

$86K - $116K/yr

The Sr Quality Engineer provides quality engineering expertise to manufacturing, engineering ... Ensure medical device regulatory requirements (21 CFR 820, EU MDD/MDR, ISO 13485:2016 and IEC 60601 ...

RAMPART IC LLC

Senior Quality Engineer

Birmingham, AL · On-site

$82K - $112K/yr

Senior Quality Engineer JOB OVERVIEW: As a Senior Quality Engineer, you will assist with the ... within the Medical Device Industry. * Candidate must be highly motivated with excellent ...

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Senior Quality Engineer Medical Device information

See salary details

$60.5K

$105.3K

$146.5K

How much do senior quality engineer medical device jobs pay per year?

As of Aug 14, 2026, the average yearly pay for senior quality engineer medical device in the United States is $105,293.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,500.00 and $120,000.00 per year, depending on experience, location, and employer.

What is a senior quality engineer medical device?

Senior Quality Engineers in the medical device industry are professionals responsible for ensuring that medical devices meet regulatory standards and quality requirements throughout their lifecycle. They lead quality assurance activities, develop and implement testing protocols, coordinate with design and manufacturing teams, and help ensure compliance with relevant regulations such as FDA and ISO standards. Their expertise ensures that products are safe, effective, and reliable for patient use. They also mentor junior engineers and may play a key role in audits and process improvements.

What is the difference between Senior Quality Engineer Medical Device vs Quality Engineer Medical Device?

AspectSenior Quality Engineer Medical DeviceQuality Engineer Medical Device
ResponsibilitiesLead quality initiatives, oversee audits, mentor team membersAssist in quality processes, support audits, perform inspections
Experience & CertificationsTypically 5+ years, often ISO 13485, FDA regulationsEntry to mid-level, basic knowledge of industry standards
Work EnvironmentLeadership roles, cross-functional teams, strategic planningOperational tasks, documentation, compliance support
Usage & IndustryCommonly used in manufacturing, R&D, and quality departmentsUsed across similar settings, often as a stepping stone role

The main difference between a Senior Quality Engineer Medical Device and a Quality Engineer Medical Device lies in experience, responsibilities, and leadership scope. Senior roles involve strategic oversight and mentorship, while standard Quality Engineers focus on supporting quality processes and compliance tasks.

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

To excel as a Senior Quality Engineer in Medical Devices, you need a solid background in engineering, quality assurance, and regulatory compliance, typically with a relevant degree and experience in the medical device industry. Familiarity with ISO 13485, FDA 21 CFR Part 820, risk management tools (such as FMEA), and quality management systems is crucial, and certifications like CQE or Six Sigma are often preferred. Strong problem-solving, attention to detail, and effective communication skills distinguish top performers in this role. These competencies ensure product safety, regulatory compliance, and the continuous improvement of processes critical to patient outcomes and company success.

How does a senior quality engineer medical device typically collaborate with cross-functional teams during product development?

As a Senior Quality Engineer in the medical device sector, you will work closely with cross-functional teams including R&D, manufacturing, regulatory affairs, and supply chain. Your role involves ensuring quality standards are integrated throughout the product lifecycle, from design reviews and risk assessments to process validation and compliance documentation. Regular meetings, joint problem-solving sessions, and clear communication are vital to resolve issues efficiently and maintain regulatory compliance. This collaborative environment helps to ensure both product safety and timely market release.
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Senior Quality Engineer Medical Device jobs near you
Infographic showing various Senior Quality Engineer Medical Device 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 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $105,293 per year, or $50.6 per hour.

Senior Quality Engineer

Tempus AI

Redwood City, CA • On-site

$108K - $146K/yr

Full-time

Re-posted 10 days ago

Tempus AI rating

7.7

Company rating: 7.7 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

147th of 244 rated software companies

Job description

Job Summary:
Tempus AI is dedicated to advancing the healthcare industry through precision medicine and AI technology. As a Senior Quality Engineer, you will lead verification, validation, and maintenance of systems supporting Tempus Medical Devices, ensuring compliance with regulatory standards and best practices in software development.
Responsibilities:
• Support regulatory compliance of the host system operating with Tempus Medical Device(s).
• Develop and maintain CSV policies, procedures, templates and work instructions.
• Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities.
• Perform validation, re-validation and change controls of various AI, SaaS, and Tempus in-house developed software.
• Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports.
• Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution.
• Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement.
• Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits.
• Provide CSV guidance, coaching, mentorship, and training to test engineers within the team.
Qualifications:
Required:
• BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
• 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)
• 3+ years experience in Computer System Validation (CSV).
• Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).
• Knowledge of quality system principles, practices, and standards for the life science industry.
• Ability to deliver quality outputs without directions or under minimal supervision.
Company:
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. Founded in 2015, the company is headquartered in Chicago, USA, with a team of 1001-5000 employees. The company is currently Late Stage.

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