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Senior Quality Engineer Medical Device Jobs (NOW HIRING)

Teleflex

INGENYX- Sr. Quality Engineer, Devices

Mansfield, MA · On-site

$93K - $127K/yr

The Sr. Quality Engineer, Devices is expected to have strong proficiency in medical device quality ... systems, design control, process validation, risk management, root cause analysis, statistical ...

Skillcloud HCM

Senior Quality Engineer

Saco, ME · On-site

$95K - $120K/yr

FISBA North America/ Senior Quality Engineer / Saco, Maine FISBA is seeking a Senior Quality ... Working knowledge of ISO 13485 quality systems and medical device manufacturing requirements.

Verily Life Sciences LLC

WI · On-site

$113 - $170/hr

Senior Quality Engineer, Cybersecurity The Senior Quality Engineer, Cybersecurity is a hands-on ... Proven expertise in medical device cybersecurity, including working knowledge of FDA premarket and ...

Skillcloud HCM

Senior Quality Engineer

Saco, ME · On-site

$95K - $120K/yr

FISBA North America/ Senior Quality Engineer / Saco, Maine FISBA is seeking a Senior Quality ... Working knowledge of ISO 13485 quality systems and medical device manufacturing requirements.

Verily Life Sciences LLC

$113 - $170/hr

Senior Quality Engineer, Cybersecurity The Senior Quality Engineer, Cybersecurity is a hands-on ... Proven expertise in medical device cybersecurity, including working knowledge of FDA premarket and ...

Cypress HCM

Senior Quality Engineer

New Hope, MN

$91K - $124K/yr

This Sr Quality Engineer is primarily responsible for providing technical support to ensure ... Previous experience with Class II or Class III medical device contract manufacturing complex ...

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Senior Quality Engineer Medical Device information

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$60.5K

$105.3K

$146.5K

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

As of Sep 3, 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.

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.

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.

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.

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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 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $105,293 per year, or $50.6 per hour.

Quality Engineer Medical Device

Egg Medical Inc

Roseville, MN • On-site

$100K - $115K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 17 days ago

Job description

Summary

We are seeking a Quality Engineer to add to our team! This position will support the management of our quality system while actively contributing to new product design and development initiatives. This role combines core quality engineering responsibilities with technical involvement in engineering projects to ensure our innovative medical devices meet the highest standards of safety, reliability, and regulatory compliance. 

Key Responsibilities

  • Quality System Support: Develop, implement, and maintain elements of the Quality Management System (QMS) to ensure ongoing compliance with FDA regulations, ISO 13485, and other applicable standards.
  • New Product Development & Design Control: Collaborate with R&D, engineering, and cross-functional teams on new design projects; support design inputs/outputs, risk assessments (e.g., FMEA, ISO 14971), design verification and validation activities, and design reviews/transfer to manufacturing.
  • Risk Management & Technical Reviews: Perform and document risk analyses, participate in technical design reviews, and ensure design controls are effectively applied throughout the product lifecycle.
  • Non-Conformance & Corrective Actions: Investigate non-conformances, lead root cause analysis, and implement corrective and preventive actions (CAPA) to drive continuous improvement and prevent recurrence.
  • Documentation & Compliance: Maintain accurate quality records, support internal/external audits, and contribute to regulatory submissions as needed.
  • Continuous Improvement: Identify opportunities to improve quality processes, product designs, and overall efficiency; partner with engineering and other teams on quality initiatives

Qualifications

  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Quality Engineering, or a related field.
  • 3+ years of experience as a Quality Engineer in a regulated industry, preferably medical devices.
  • Experience with FDA regulations, ISO 13485, and other medical device quality standards.
  • Proficiency in quality tools and methodologies (e.g., FMEA, SPC, CAPA).

Compensation & Benefits

  • Full-time position with salary range from $100,000-$115,000, depending on experience.
  • Additional bonus/incentive compensation available.
  • Company laptop provided.
  • Insurance available on the 1st of the month following date of hire, including: health, dental and vision insurance, plus pre-tax or Roth 401k available after 30 days.
  • PTO accrues starting at 15 days, plus 11 company paid holidays.

Company Description

Egg Medical is an innovative leader in radiation safety protection technology. Our mission is to protect healthcare professionals from occupational radiation exposure while enabling the delivery of exceptional patient care.