Job Description
Job Description
Job Title: Senior Quality Engineer
Location: Hayward, CA (Onsite)
Employment Type: Full-Time
Visa Sponsorship: Not Available at this time
Job Summary
We are seeking a Senior Quality Engineer to support quality system implementation and compliance activities for Class II/III medical devices. This role will contribute to product development, manufacturing, regulatory, and clinical efforts by ensuring compliance with FDA QSR (21 CFR 820) and ISO 13485 requirements. The ideal candidate has hands-on experience supporting medical devices from development through commercialization in a fast-paced environment.
Responsibilities
- Support and maintain Quality Management Systems compliant with FDA QSR and ISO 13485
- Provide quality engineering support for design controls, design assurance, and compliance activities
- Lead risk management activities per ISO 14971, including planning, analysis, and reporting
- Develop and maintain traceability matrices and verification documentation
- Manage biocompatibility and sterilization activities, including protocol development and testing execution
- Establish and improve quality engineering processes and methodologies
- Support manufacturing qualification, process validation, and ongoing production quality
- Perform data analysis, statistical evaluations, and participate in MRB activities
- Support regulatory submissions, audits, and management reviews (including MDSAP / Notified Body audits)
- Assist with labeling, UDI compliance, and documentation for clinical and commercial use
Qualifications
- Bachelor’s degree in Engineering, Science, or related field
- Minimum 5 years of Quality Engineering experience in the medical device industry
- Experience supporting Class II/III medical devices
- Strong knowledge of FDA QSR (21 CFR 820 & 21 CFR 11)
- Working knowledge of ISO 13485, ISO 14971, and MDR requirements
- Experience with ISO 10993 (biocompatibility)
- Knowledge of AAMI/ISO 11135 and 11137 (sterilization)
- Familiarity with ISO 11607 and ASTM D4169 (packaging and distribution testing)
- Experience supporting products from development through commercialization
- Cardiovascular or interventional device experience preferred
- Proficient with Microsoft Office applications
- Strong written and verbal communication skills
Additional Requirements
- Ability to work onsite in Hayward, CA
- Ability to travel up to 10%
- Ability to lift up to 10–15 lbs
Compensation
Base Salary Range: $115,000 – $140,000 (Northern California)
Compensation is based on job-related skills, experience, education, and location.