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Quality Engineer Medical Device Jobs (NOW HIRING)

Astrix Inc

Quality Engineer II

Irvine, CA · On-site

$77K - $99K/yr

Pay Rate Low: 40.00 | Pay Rate High: 44.00 Exciting Quality Engineer II development opportunity to ... Working knowledge of ISO 13485, ISO 14971, and medical device quality systems. * Strong ...

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

Medical Device Quality Engineer Location: Madison, WI Pay Rate : $40--45/hr on W2 Schedule: Onsite, Monday-Friday (standard business hours) Summary The Senior Quality Analyst/Engineer is responsible ...

Caraballo Consulting & Associates L

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QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

We are seeking a Quality Manufacturing Engineer extensive experience in Medical Devices to oversee Manufacturing Quality projects and line transfers for a Medical Device company. The perfect ...

Caraballo Consulting & Associates L

Be Seen First

QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

We are seeking a Quality Manufacturing Engineer extensive experience in Medical Devices to oversee Manufacturing Quality projects and line transfers for a Medical Device company. The perfect ...

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

As of Aug 27, 2026, the average hourly pay for quality engineer medical device in the United States is $36.72, according to ZipRecruiter salary data. Most workers in this role earn between $24.76 and $45.91 per hour, depending on experience, location, and employer.

What does a quality engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

What are the key skills and qualifications needed to thrive as a quality engineer in the medical device industry?

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

How does a quality engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.

What is the difference between Quality Engineer Medical Device vs Quality Assurance Specialist Medical Device?

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

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Quality Engineer Medical Device jobs near you
Infographic showing various Quality Engineer Medical Device job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, and 6% Contract. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution, with an average salary of $76,384 per year, or $36.7 per hour.

Quality Engineer II

Astrix Inc

Irvine, CA • On-site

$77K - $99K/yr

Contractor

Medical, Dental, Vision, Retirement, PTO

Re-posted 9 days ago

Job description

Pay Rate Low: 40.00 | Pay Rate High: 44.00
Exciting Quality Engineer II development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses in Surgical and Vision Care
Quality Engineer II
Location: Irvine, CA (Onsite)
Contract: 12 month Contract with extension or conversion potential
Benefits: Medical, Dental, Holiday, PTO 401K matching
Pay: 40.00-44.00 doe
Quality Engineer - Medical Devices
Provide hands-on quality engineering support for new product development and design changes for instrumentation products. Partner with R&D, Regulatory, and cross-functional teams throughout the product development lifecycle.
Key Responsibilities:
  • Support design controls, risk management, verification/validation, change control, and product transfer.
  • Review and approve design control, risk management, V&V, and development documentation.
  • Provide quality guidance and risk-based decision support to development teams.
  • Assess product and process changes for quality and regulatory impact.
  • Support deviation investigations, root cause analysis, and CAPA activities.
  • Ensure compliance with ISO 13485, ISO 14971, GxP, SOPs, and applicable regulatory requirements.

Minimum Qualifications:
  • Bachelor's degree in Engineering, Life Sciences, or related technical field.
  • 2+ years of Quality Engineering experience in the medical device industry.
  • Experience supporting instrumentation or electromechanical product development in an ISO 13485 environment.
  • Experience with design controls, risk management, change control, and V&V.
  • Working knowledge of ISO 13485, ISO 14971, and medical device quality systems.
  • Strong communication, collaboration, and independent problem-solving skills.

Preferred:
  • Experience with statistical methods and V&V study design.
  • Knowledge of IEC 60601 and other applicable product/safety standards.
  • ASQ CQE or Six Sigma certification.

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
Work Authorization Requirement
Candidates must be authorized to work in the United States on a permanent basis.
Sponsorship (including H-1B, OPT, CPT, etc.) is not available for this role now or in the future.
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