Senior Quality Assurance Engineer (Medical Devices)

Location: On-site in Sunnyvale and/or Newark, California, United States. Up to 10% domestic and international travel required.

Salary: $116,000–$159,500 annual base salary, plus bonus/incentive eligibility.

Company

hirify.global’s Cepheid operating company develops fast, accurate molecular diagnostic systems and tests for healthcare and life sciences applications.

What you will do

• Provide day-to-day quality engineering support for medical device manufacturing, including plastic part design, manufacturing equipment performance, and quality inspections.
• Represent Quality Engineering on cross-functional new product introduction and manufacturing sustainment teams.
• Lead risk assessments, including safety, design, and process FMEAs, as well as verification and validation planning.
• Develop and review quality plans, validation master plans, risk management plans, control plans, and IQ/OQ/PQ/PV protocols and reports.
• Investigate nonconformities and deviations, identify root causes, define dispositions, and support corrective and preventive actions.

Requirements

• Bachelor’s degree in mechanical, industrial, biomedical engineering, or a related field with 5+ years of quality engineering experience, or a master’s degree with 3+ years of quality experience.
• Strong knowledge of ISO 13485, 21 CFR 820, and GMP requirements.
• Experience with NPI Quality, complex systems, design verification and validation, part and process qualification, and automation equipment qualification.
• Ability to work on-site in Sunnyvale and/or Newark, California.
• Ability to travel domestically and internationally for up to 10% of the time.

Nice to have

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

Culture & Benefits

• Work within hirify.global’s continuous improvement system and a quality engineering team focused on measurable healthcare impact.
• Comprehensive benefits including paid time off and medical, dental, and vision insurance.
• 401(k) plan available to eligible employees.
• Bonus or incentive compensation eligibility.