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Principal Quality Engineer

Reports to: Senior Director Regulatory Affairs

 

Job Location: Redwood City, CA

Job Summary:

Leads Quality Engineering activities from early design development stages to product implementation in manufacturing. In charge of quality planning and Quality strategy for the development and qualification of Exo’s products to meet applicable FDA and European regulations. Ensures compliance with company’s quality system policies and procedures, as well as awareness and fulfillment of Design Control deliverables. Promotes quality mentality and best medical device practices throughout the organization. Supports generation of data for regulatory submissions.

 

Job Responsibilities (including but not limited to):

  • Risk Management process per ISO 14971

  • Creation and coordination of Design V&V test plans and Requirements Traceability Matrix

  • Coordination of electrical safety, biocompatibility, cleaning & disinfection and other qualification testing with external vendors

  • Oversight and guidance for Software Lifecycle activities to fulfill requirements of IEC 62304

  • Process Validation strategy and execution

  • Supplier qualifications and coordination of quality plans, PFMEAs and process validations with critical vendors

  • Resolution of quality issues, participation in failure analysis

  • Design History File and Device Master Record

Education/Experience Requirements:

  • BS degree in an engineering field with a minimum of 7 years of experience in medical devices 

  • 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 atiwari@exo.inc

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