On behalf of our client, a pioneering, well-funded startup in the medical device space, we are seeking a Principal Quality Engineer to serve as a cornerstone of their technical team. This is a critical hire for a company moving through key development milestones in the Fremont/Newark area.
The ideal candidate will be a subject matter expert in design controls and quality engineering, possessing the "startup grit" necessary to navigate the transition from product development to ongoing manufacturing. Our client is looking for a leader who can ensure that every aspect of their innovative technology meets FDA cGMP and ISO 13485 standards while maintaining the agility of a high-growth environment.
Key Responsibilities
Product Development & Design Assurance
- Provide Quality Engineering leadership to cross-functional teams throughout the entire Product Development Process (PDP).
- Ensure all products are developed in strict accordance with FDA cGMP, ISO 13485, and global regulatory requirements.
- Author and manage comprehensive risk management files, including DFMECA, PFMECA, and CFMECA.
- Lead design verification and validation (V&V) efforts, including environmental, accelerated aging, and packaging testing.
- Develop and oversee biocompatibility testing protocols and reports.
Manufacturing & Supplier Quality
- Manage quality relationships with Contract Manufacturers (CMOs), overseeing process validations and capability studies (IQ/OQ/PQ).
- Provide direct support for medium-volume, hand-built assemblies and processes such as heat sealing, bonding, and specialized packaging.
- Oversee Controlled Environment Room (CER) qualifications, maintenance, and continuous monitoring.
- Write and refine manufacturing process instructions to guarantee product reliability.
Continuous Improvement & Root Cause Analysis
- Perform rigorous failure and root cause analysis for internal non-conformances and customer complaints.
- Apply advanced statistical techniques and Statistical Process Control (SPC) to monitor and improve manufacturing yields.
- Identify and execute Corrective and Preventive Action (CAPA) plans and maintain risk management documentation for product design.
Requirements
- Experience: Minimum of 10 years in a cGMP/QA environment within the medical device or pharmaceutical industry.