Quality Engineer – Validation and IVDR Focus

Quantimetrix is a leader in the development and manufacturing of clinical laboratory quality controls. Proudly based in Redondo Beach for over 50 years, we’re an employer of choice delivering industry-leading products and services to the global medical community. We're looking for a well-qualified and passionate Quality Engineer to join our dedicated team.

Do precision, quality, and innovation drive you? At Quantimetrix, we’ve spent over 40 years designing world-class lab quality control products that help ensure accurate diagnostic results around the globe. We’re seeking a Quality Engineer to play a key part in driving quality excellence and regulatory compliance across our organization. If you’re ready to grow your career, bring your passion to Quantimetrix!

At Quantimetrix, we’ve been pioneering liquid-stable lab quality controls for over 40 years—right from our Redondo Beach HQ. Our team is driven by Integrity, Quality, and Innovation (iQi), creating products that advance lab testing and improve patient care worldwide. With decades of experience and a passion for problem-solving, we always seek curious, committed minds to help push technology forward.

Best-in-Class Benefits and Perks:

We value our employees’ time and efforts. Our commitment to your success is enhanced by competitive compensation of $90,000 – $110,000 annually, depending on experience, and an extensive benefits package including:

• Comprehensive health coverage: Medical, dental, and vision insurance provided
• Robust retirement planning: 401(k) plan available with employer matching
• Financial security: Life and disability insurance for added protection
• Flexible financial options: Health savings and flexible spending accounts offered
• Well-being and work-life balance: Tuition assistance program, paid time off, flexible schedule, and remote work choices provided

As a Quality Engineer focused on validation, you will play a critical role in supporting our Quality team and ensuring compliance with FDA QSR, ISO 13485, MDSAP, IVDR, and Health Canada regulations. You will lead and support validation activities across equipment, processes, and software, including developing and reviewing IQ, OQ, and PQ protocols and reports. You will conduct risk assessments, contribute to the continuous improvement of our Quality System, and drive quality engineering initiatives across departments. In this role, you will collaborate closely with cross-functional teams while working independently to meet key objectives. Strong communication and technical writing skills will be essential as you prepare clear, concise documentation and help maintain a culture of quality and compliance throughout the organization.

As a Quality Engineer, you should have:

• Bachelor’s degree in Science or Engineering
• 5+ years in pharmaceutical or medical device quality engineering/validation
• Solid understanding of FDA QSR and ISO 13485; experience with IVDR and design controls is a plus
• Proficiency in Excel, data analysis, and statistical tools
• Skilled in validation documentation, risk analysis (FMEA), and quality tools (Pareto, SPC)
• Exceptional technical writing and communication skills
• ASQ Quality Engineering Certification preferred

Your Responsibilities as a Quality Engineer Will Include:

• Lead and support validation activities for equipment, processes, shipping, and systems (IQ/OQ/PQ)
• Ensure compliance with FDA QSR, ISO 13485, MDSAP, IVDR, and Health Canada regulations.
• Author and review validation protocols, reports, and quality documentation (SOPs, work instructions)
• Support test method development and validation for current and new products
• Provide QA input on risk analysis, design controls, and regulatory compliance
• Conduct quality investigations (NCMRs, CAPAs), root cause analysis, and contribute to continuous improvement

Join us on the journey of excellence and innovation. Apply now and be a part of something extraordinary!

Ready to take the lead in our manufacturing revolution? If you're excited to drive change, inspire a team, and make a lasting impact, we want to hear from you! Please email your resume and cover letter to: [email protected]

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Qualified applicants with arrest or conviction records will be considered for employment with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.