Quality Engineer

Job title: Device Engineer - VLocation: Foster City CADuration: 12+ MonthsPay rate:$80 - $100/hr.OverviewThe Device Engineering team is seeking a highly organized and detail-oriented Senior Technical Specialist to support drug-device combination products throughout their commercial lifecycle. This role is critical in ensuring compliant change management, effective cross-functional coordination, and ongoing product quality within a regulated environment.Key ResponsibilitiesChange Control ManagementInitiate, coordinate, and close change control records for product and manufacturing process updates Manage change records related to design and development activities for combination products Support the creation and maintenance of design control documentation Test Sample CoordinationManage test sample requests, procurement, and tracking Coordinate logistics for timely delivery of test samples across teams and external partners Post-Market Surveillance & Risk ManagementCompile and analyze post-market surveillance data for annual reporting Generate risk summaries and maintain risk management files Support complaint investigations and ensure proper documentation Cross-Functional CollaborationWork closely with internal teams, vendors, suppliers, and contract manufacturers to coordinate changes and ensure compliance Support quality and regulatory activities aligned with global standards Required QualificationsBachelor’s degree (BS/BA) in Engineering, Life Sciences, or a related field 3–5 years of experience in medical devices, pharmaceuticals, or combination products Experience working in a regulated environment (cGMP/GMP) Preferred QualificationsExperience with drug-device combination products Working knowledge of global regulations (US, EU, international) Familiarity with Veeva Vault or similar quality management systems Experience with risk management tools (e.g., FMEA, ISO 14971) Exposure to design controls and product development processes Key SkillsStrong organizational and time management abilities Excellent project coordination skills Attention to detail and documentation accuracy Ability to manage multiple priorities in a fast-paced environment Effective communication and collaboration skills Nice to HaveDevice development experience (for candidates aligning with Sr Device Engineer level)