Senior Quality Assurance Engineer

Danaher Corporation•Sunnyvale, CA

7d•$116,000 - $159,500•Onsite

About The Position

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.

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 automation equipment qualification.

Nice To Haves

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

Responsibilities

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.