Senior Quality Engineer for Medical Devices & NPI

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

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.