Senior Quality Assurance Engineer

Danaher Corporation • Newark, CA

1d • Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible. The Senior Quality Engineer is responsible for supporting the development and sustainment of Medical Device manufacturing operations by applying a rigorous, risk‑based approach that ensures compliance with corporate policies, 21 CFR 820, ISO 13485, and other relevant regulatory standards. In this role, you will play a pivotal part in supporting production development, enhancing automation equipment performance, and elevating manufacturing quality controls to support fast paced, high‑yield operation. These efforts enhance manufacturing reliability, strengthen process capability, and provide strong quality leadership that drives the continuous improvement. This position reports to the Sr Manager of Quality Engineering and is part of the Quality Engineering Team located in Newark, CA, and will be an on-site role.

Requirements

• BS degree in mechanical, industrial, biomedical engineering, or related field with 5+ years of quality engineering experience or master’s degree with 3+ years’ of quality experience.
• Strong understanding of ISO 13485, 21 CFR 820, and GMP requirements.
• Proven experience in NPI Quality and working with complex systems, including design verification and validation, part and process qualification, and the qualification and validation of automation equipment.
• Ability to travel domestically and internationally for up to 10% of the time.

Nice To Haves

• Experience in medical device manufacturing or biomedical
• Experience in biochip and post-fab wafer‑processing operations
• Certified Quality Engineer and/or Lead Auditor certification

Responsibilities

• Lead daily quality engineering support for medical device manufacturing operations, including oversight of critical processes, equipment performance, and in‑line quality inspections.
• Serve as the primary Quality Engineering representative on cross‑functional teams for automation equipment and manufacturing process development/sustainment activities.
• Drive risk assessment activities, including process FMEAs, to assist manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution.
• Develop and review project documentation such as quality plan, validation master plan, risk management plan, quality control plan and IQ/OQ/PQ protocols and reports to ensure full compliance with regulatory requirements and Cepheid Quality Management System.
• Address nonconformities and deviations by performing risk assessments, identifying root causes, conducting failure mode analysis, defining disposition, and supporting effective corrective and preventive actions to prevent recurrence.

Benefits

• Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or flexible time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
• We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level