Principal Quality Engineer, Product Development
Reports to: Director of Regulatory & Compliance
Job Location: Redwood City, CA
Represents the QA/RA Department from early design development stages to product implementation in manufacturing. Independently develops the Quality plan and Quality strategy for the development of an electromechanical medical device with embedded software. As a project team member, the individual will be responsible for ensuring compliance with company’s Quality System policies and procedures, as well as awareness and fulfillment of Design Control deliverables.
Responsible for Risk Management activities, requirements Traceability Matrix, creation of Design V&V test plans, coordination of electrical safety / cleaning & disinfection testing with external vendors, assembly of Design History File, creation of Process Validation Plans etc. Coordinates quality and process validation plans with critical vendors, conducts supplier qualifications and provides feed-back to suppliers on meeting specifications. Participates in failure analysis and facilitates resolution of quality issues.
BS degree with a minimum of 7 years of experience in medical device manufacturing and product development.
Must be able to make technical decisions independently, provide technical guidance to other team members and assume high levels of responsibility. Must have strong knowledge of medical device GMPs and ISO 13485. Working knowledge of ISO 14971, IEC60601 series and IEC62304 highly desired. Superior time management skills, ability to work on several projects simultaneously and excellent communication skills required.
Available to travel up to 15% of the time.
If interested, please send resume and cover letter to firstname.lastname@example.org