Overview
Product Quality Engineer Jobs in Santa Cruz County, CA at BioTalent
Title: Product Quality Engineer
Company: BioTalent
Location: Santa Cruz County, CA
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:
Bachelor’s degree in Engineering, Life Sciences, or related field.
3+ years of quality engineering experience in the medical device industry, preferably with pre-market products.
Strong understanding of design control, risk management, and V&V testing.
Experience with ISO 13485, FDA regulations, and product development processes.
Knowledge of biocompatibility, sterilization validation, and usability engineering is a plus.
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!
