Senior Quality Engineer – Medical Device NPI & Compliance

Cepheid

Newark (CA)

On-site

USD 116,000 - 160,000

Full time

14 days+

Application generator

A complete application in a minute — tailored resume and cover letter, ready to send.

Get past ATS filters

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Time off

Job summary

Cepheid, a Danaher operating company, is seeking a Senior Quality Engineer to drive manufacturing and product lifecycle quality through risk-based approaches and robust change control. This on-site role in Sunnyvale and/or Newark, CA collaborates across teams to ensure compliance with 21 CFR 820, ISO 13485, and GMP, supporting NPI and manufacturing sustainment.

You will develop qualification strategies, review change orders, and mitigate risks across design and process modifications, ensuring

Qualifications

BS degree in mechanical, industrial, biomedical engineering; 5+ years quality engineering experience
Strong understanding of ISO 13485, 21 CFR 820, and GMP requirements
Experience in NPI Quality and design transfer, including verification/validation
Ability to travel domestically and internationally up to 10% of the time

Responsibilities

Lead day-to-day quality engineering support for medical device manufacturing operations.
Serve as primary QE on cross-functional teams for NPI and manufacturing sustainment.
Drive risk assessment activities including design and process FMEA with V&V planning/execution.
Develop and review quality documentation: QCP, VMP, risk management plan, QC protocols and reports.
Address nonconformities with risk assessments, root cause analysis, and CAPA.