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San Francisco Bay Area, CA

  • Senior Quality Engineer

    Sunnyvale, CA

    Summary:

    The Senior Quality Engineer will be helping to advance the innovative and practical solutions associated with the diagnosis and treatment of vertebrogenic pain. This position is responsible for quality assurance department deliverables and addressing quality issues in alignment with the company’s strategic goals, objectives, resources, and priorities. This individual will support a growing environment focused on mitigating quality risks that may impact the company and it’s customers.

    Essential Functions:

    • Function as a contributing technical member of multidisciplinary project teams in the design, development, and manufacturing of energy based and non-energy based spinal products.
    • Partner with Suppliers to add and/or maintain them on the Approved Supplier List.
    • Work with Suppliers to initiate, process and close Supplier Corrective Actions (SCARs).
    • Lead and perform supplier quality audits for contract manufacturers.
    • Drive Corrective and Preventive Actions (CAPAs) by performing investigations, creating Corrective Action Plans and Verification Plans, Implementing Corrective Action Plans, and Verifying Effectiveness of the Actions.
    • Process and assist in the investigation and closing of Complaints in a timely manner.
    • Develop and assist others in the development of Quality System documents such as protocols, procedures, work instructions, and equipment specifications.
    • Respond to changes in regulations by updating protocols, procedures and work instructions to maintain compliance.
    • Develop and complete Quality System records as required for the return of product (RMAs), inspection of product (QTMs), and accurate maintenance of required Logs.
    • Train to and execute Quality System processes in alignment with the Quality System and all applicable regulatory and quality standards.
    • Assist other members of QA and RA with the Engineering Change Order system as needed.
    • Able to travel to vendors, labs, and customers as needed.

    Education:

    • BS or MS in Engineering.

    Experience:

    • 5+ years of experience in quality engineering.
    • 5+ years of experience in the medical device industry.
    • Experience with in-depth understanding of quality management systems in FDA, ISO 13485, and MDD/MDR regulatory environment.

    Skills/Aptitudes:

    • Versatility, flexibility, and a willingness to work within constantly changing priorities in a rapidly growing company with enthusiasm.
    • Solid understanding of quality engineering principles and quality assurance systems.
    • Proficient with using personal computers (Mac preferred) and common spreadsheet, word processing, statistical analysis software and email applications.
    • Quality Engineering certification(s) a plus.


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