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Quality Engineer Medical Device Jobs in California

Astrix Inc

Quality Engineer II

Irvine, CA · On-site

$77K - $99K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

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 ...

Talentry, LLC

Be Seen First

Sr. Mechanical Engineer - Medical Device

San Diego, CA · On-site

$130K - $180K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Senior Mechanical Engineer - Medical Device San Diego, CA (Onsite) 130,000-180,000 DOE Join a ... You'll work closely with systems, electrical, quality, regulatory, operations, and lab teams to ...

Heartflow

Senior Device Quality Engineer

San Francisco, CA · On-site

$160K - $180K/yr

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery ... As the Senior Device Quality Engineer , you will serve as a key technical lead for software quality ...

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Mizuho OSI

Systems Engineer, Medical Device

Union City, CA · On-site

$82K - $150K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

... Systems Engineer you will be part of a small, agile team; responsible for medical device ... Understand, follow and support Mizuho OSI's internal Quality System policies, procedures and work ...

Mizuho Osi

Systems Engineer, Medical Device

Union City, CA · On-site

$82K - $150K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

... Systems Engineer you will be part of a small, agile team; responsible for medical device ... Understand, follow and support Mizuho OSI's internal Quality System policies, procedures and work ...

Mizuho OSI

Systems Engineer, Medical Device

Union City, CA · On-site

$82K - $150K/yr

... Systems Engineer you will be part of a small, agile team; responsible for medical device ... Understand, follow and support Mizuho OSI's internal Quality System policies, procedures and work ...

Astrix Inc

Instrumentation Quality Engineer

Lake Forest, CA · On-site

$76K - $98K/yr

  • Medical

  • Dental

  • Retirement

  • PTO

Medical, Dental, Holiday, PTO 401K matching We are seeking an Instrumentation Quality Engineer to support medical device product development and quality activities. This role partners with R&D, ...

UL Solutions

Staff Engineer - Medical Device

Brea, CA · On-site

$115K - $160K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Resolves engineering issues associated with Variation Notices by analyzing and reporting on the ... Performs quality systems and technical audits of customer laboratories. * Performs other duties as ...

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All JobsQuality Engineer Medical Device JobsQuality Engineer Medical Device Jobs in California

Quality Engineer Medical Device information

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 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.

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.
More about Quality Engineer Medical Device jobs

What are the most commonly searched types of Quality Engineer Medical Device jobs in California?

The most popular types of Quality Engineer Medical Device jobs in California are:

What are popular job titles related to Quality Engineer Medical Device jobs in California?

For Quality Engineer Medical Device jobs in California, the most frequently searched job titles are:

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The top searched job categories for Quality Engineer Medical Device jobs in California are:

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Cities in California with the most Quality Engineer Medical Device job openings:

Quality Engineer Medical Device jobs near you
Infographic showing various Quality Engineer Medical Device job openings in California as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, 2% Temporary, and 5% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Senior Quality Engineer Medical Device

Grove Technical Resources

California City, CA • On-site

$108K - $147K/yr

Other

This job post has expired today. Applications are no longer accepted.

Job description

Sr Quality Engineer – Medical device Location: Irvine, CA ( Fully Onsite) Duration: 12 Months Work Schedule: Fully Onsite – 5 Days/Week Position Summary The Sr Quality Engineer will support manufacturing quality and compliance for Medtronic Neurovascular products, including embolic coils, stents, catheters, balloons, aspiration devices, coatings, and guidewires. This role will focus on process quality, validation, risk management, CAPA, nonconformance investigations, statistical analysis, and continuous improvement within a regulated medical device manufacturing environment. Key Responsibilities Develop, implement, and maintain quality standards and procedures for manufacturing processes and finished products. Partner with Manufacturing, Process Engineering, R&D, and Regulatory teams to resolve quality and process issues. Conduct inspections, testing, process evaluations, and statistical analysis to ensure product and process requirements are met. Troubleshoot manufacturing and equipment issues and drive effective technical resolutions. Lead root cause investigations using tools such as 5 Whys, 6M, Ishikawa, and Pareto analysis. Manage CAPA and NCMR investigations and implement corrective and preventive actions. Perform risk assessments using FMECA, DFMECA, and PFMECA methodologies. Develop and execute process validation and verification activities, including IQ, OQ, and PQ. Support Test Method Validation (TMV) and related documentation. Apply statistical process control, process capability, measurement system analysis, and tolerance interval techniques using Minitab. Support lean manufacturing and Six Sigma initiatives to improve process efficiency and product quality. Ensure manufacturing documentation, specifications, procedures, and sampling plans comply with applicable requirements. Provide technical guidance, training, and mentorship to junior quality engineers and technicians. Required Qualifications Bachelor’s degree in Engineering, Science, or a related technical field. 4+ years of relevant quality engineering experience; advanced degree with 2+ years may be considered. Medical device manufacturing experience strongly preferred. Minimum 2 years of experience with:FDA 21 CFR Part 820, ISO 13485, ISO 14971, and GMP FMECA, DFMECA, PFMECA, and risk management Process Verification & Validation (IQ/OQ/PQ) Test Method Development and Validation (TMV) Root Cause Analysis and quality tools Six Sigma and Lean Manufacturing CAPA and NCMR investigations Minitab, statistical analysis, process capability, and MSA Manufacturing quality documentation, specifications, procedures, and sampling methods Preferred Experience Experience with vascular or neurovascular medical devices such as stents, catheters, embolic coils, guidewires, balloons, or aspiration devices. Strong understanding of manufacturing processes and process controls. Experience working in a highly regulated medical device environment. Ability to work independently, manage complex quality issues, and influence cross-functional teams.

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