What are the responsibilities and job description for the Product Quality Engineer position at BioTalent?
Product Quality Engineer – Pre-Market Medical Devices
Location : San Francisco Bay Area
A fast-growing medical device company focused on pre-market Class II / III products is seeking a Product Quality Engineer to support the development and regulatory approval of innovative medical technologies. This role will play a critical part in ensuring design, development, and risk management activities meet regulatory and quality standards before market approval.
Key Responsibilities :
- Provide quality engineering support throughout the product development lifecycle, ensuring compliance with FDA 21 CFR 820, ISO 13485, and ISO 14971.
- Work closely with R&D and Regulatory teams to develop design controls, risk management files, and verification / validation plans.
- Support the creation and execution of design verification and validation (V&V) testing.
- Assist in developing product and process risk assessments (FMEAs).
- Ensure compliance with Good Documentation Practices (GDP) and participate in internal audits and regulatory submissions.
- Collaborate with suppliers and manufacturing partners to establish incoming quality requirements for components and materials.
Qualifications :
This is an exciting opportunity to be at the forefront of developing innovative medical technologies before they reach the market. If you're passionate about quality engineering in early-stage medical devices, apply today!
