Senior Quality Assurance Engineer

Cepheid; Sunnyvale (CA); On-site; USD 116,000 - 160,000; Full time

Benefits offered by this job

Bonus potential

Health insurance

401(k)

Job summary

Cepheid, a Danaher operating company, is seeking a Senior Quality Engineer to drive manufacturing and product lifecycle quality in Sunnyvale and/or Newark, CA. This on-site role focuses on risk-based quality strategy, design control, and continuous improvement across the product lifecycle.

You will contribute to New Product Introduction, change control, and supplier quality, coordinating with cross-functional teams to ensure compliance with ISO 13485, 21 CFR 820, and GMP requirements.

Qualifications

• BS degree in mechanical, industrial, biomedical engineering or related field.
• 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 automation equipment qualification.

Responsibilities

• Lead day-to-day quality engineering support for medical device manufacturing operations, including oversight of design control, risk management, and quality inspections.
• Serve as the primary Quality Engineering representative on cross-functional teams for new product introduction and manufacturing sustainment.
• Drive risk assessment activities including safety, design and process FMEA with focus on verification/validation planning and execution, and remediation of issues.

Skills

Quality engineering

NPI quality

Risk assessment

Design verification

Validation

Education

BS degree in mechanical/industrial/biomedical engineering

Master’s degree in related field

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

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 driving manufacturing and product lifecycle quality by implementing a risk-based approach to ensure compliance with corporate policies, 21 CFR 820, ISO 13485, and other applicable regulatory standards, while championing continuous improvement. You will play a pivotal role in New Product Introduction (NPI) and Change Control processes, ensuring accurate and complete quality deliverables during design transfer to manufacturing. This includes reviewing change orders and deviations to confirm clear, well-documented rationales and comprehensive impact assessments for significant changes. By developing robust qualification strategies, you will proactively mitigate risks associated with design and process modifications, enhancing product reliability and supporting innovative product development. This position reports to the Sr Manager of Quality Engineering and is part of the Quality Engineering Team located in Sunnyvale and/or Newark, CA, and will be an on-site role.

In This Role, You Will Have The Opportunity To

• Lead day-to-day quality engineering support for medical device manufacturing operations, including oversight of plastic part design, manufacturing equipment performance, and quality inspections.
• Serve as the primary Quality Engineering representative on cross-functional teams for new product introduction and manufacturing sustainment, providing strategic input on design control, risk management, and quality compliance.
• Drive risk assessment activities including safety, design and process FMEA(s), with a focus on interpretation of quality requirements, verification/validation planning and execution, first production run requirements, and potential problem resolution.
• Develop and review project documentation such as quality plan, validation master plan, risk management plan, quality control plan, IQ/OQ/PQ/PV 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.

The Essential Requirements Of The Job Include

• 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 automation equipment qualification.

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Ability to travel domestically and internationally for up to 10% of the time.

It would be a plus if you also possess previous experience in:

• Experience in medical devices or pharmaceutical manufacturing
• Certified Quality Engineer and/or Lead Auditor certification

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

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.

The annual salary range for this role is $116,000-159,500. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].