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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 ...

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:

What job categories do people searching Quality Engineer Medical Device jobs in California look for?

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

What cities in California are hiring for Quality Engineer Medical Device jobs?

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.

Quality Engineer (Medical Device-Spine)

TOP DOGG STAFFING

San Diego, CA

$91K/yr

Full-time

Re-posted 11 days ago

Job description

The Position Quality Engineer (Medical Device-Spine) Medical Equipment / Devices Information Technology - Quality Assurance Full-time United States - California - San Diego - Vista The Compensation $ 80,000 -$91,000 Benefits - Full Relocation Assistance Available - No Commission Compensation - No Bonus Eligible - Yes Overtime Eligible - No Interview Travel Reimbursed - No Detailed Description The Quality Engineer's responsibilities include assisting with the development of quality systems, procedures and controls to ensure that products consistently meet performance and quality specifications. The Quality Engineer is a leader and strong technical resource who quickly, effectively and permanently resolves quality problems with internal and external customers and suppliers. Primary responsibilities are to: Take a leadership role on customer complaints to identify, coordinate and effectively resolve problems in a timely manner and maintain GMP and ISO 13485 compliance Responsible for complaint evaluations, analysis, trending and reporting of complaint data using standard statistical techniques and complaint processing and presentation software Assist with providing a strong quality direction in new product development and design change efforts to ensure that products meet performance/quality specifications and are highly manufacturable Assist with the development of critical-to-quality specifications, test plans, protocols, procedures, tools, meaningful metrics and controls for all aspects of manufacturing, packaging, cleaning, sterilization, inspection and shipping Assist with the development of plans and oversee the qualification of new suppliers and raw materials domestically and internationally Work to quickly and permanently resolve supplier quality issues Establish procedures for statistical methods (DOE, sampling, and ANOVA) Specify and design inspection, test methods, fixtures, and set-ups for the Quality Control Department and vendors Develop and implement policies, procedures and work instructions for the Quality Control Department Manage equipment, preventative maintenance, and instrument calibration process and documentation More About the Position 40+ Hours per Week Visa Candidates Considered - No The Candidate 2+ to 5 years of experience Management Experience Required - No Minimum Education - Bachelor's Degree Willingness to Travel - Occasionally The Ideal Candidate The ideal candidate has worked for these companies: Medtronic, DePuy, Synthes, Stryker, Nuvasive, Zimmer.

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