Quality Engineer

2 weeks ago

South San Francisco, United States Spirair, Inc. Full time

Spirair, a venture capital backed medical device company, was co-founded by two Stanford Biodesign and Innovation fellows with a shared interest in optimizing outcomes and patient experience through innovation solutions. With a passion for developing elegant technologies that evolve care and enhance accessibility and effectiveness, the Spirair team is partnering with leading ENT advisors and industry veterans to offer treatment options that are both massively impactful and minimally invasive.We are looking for a Quality Engineer who is responsible for supporting Spirair's Quality Management System. This role will interface with the R&D and the Operations teams on Quality support for new product development and ongoing manufacturing. Essential Responsibilities include the following (other duties may be assigned): QMS Support: Assist with Document Control initiation, routing, approval and release of documents. Assist with training compliance for company. Provide input and support in selection, implementation and validation of eQMS system. Lead complaint investigations and reporting. Track returned materials, investigate returned and unreturned product. Be able to use root cause analysis tools and methodology. Initiate, complete and close complaint reports. Identify and drive corrective actions. Product Quality: Provide incoming inspection support, review of lot history documentation. . Head Material Review Board activities for nonconforming material and drive resolution and closure of NCMRs. Approve and monitor supplier performance and perform supplier audits, as required. Equipment and Process Controls: Review /approve inspection and manufacturing equipment creation and release. Function as key Quality contact for contract manufacturer, including on-site support and troubleshooting as needed Assist on manufacturing line and investigate issues. Perform process validations, write protocols and reports and assist in development of test methodology and fixturing. Design Controls: Represent Quality issues on new product development team including participating in risk management, test protocol development and quality plans. Continuous Improvement: Participate in investigation and closure of CAPAs. Compile and report on quality metrics, including monthly dashboard and management review meetings. Assist with continued development of company's standard operating procedures. Other duties as assigned. This role will support the manufacturing of a sterile medical device manufactured in a controlled environment, so previous experience in this environment a plus. Requirements 5+ years related experience in the area of quality engineering for medical device manufacturer Working knowledge and application of FDA QSRs and ISO 13485, MDD requirements. Audit experience a plus. BS degree. Excellent communication, interpersonal and organizational skills Ability to collaborate in a team environment as well as work independently. Self-starter with the ability to manage multiple projects in a dynamic environment BenefitsSpirair offers highly competitive salaries, equity, and benefits, including medical, dental, and vision insurance, paid time off, and 401(k). Legal authorization to work in the US is required. We are not able to sponsor individuals for employment visas for this job. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment verification form upon hire. This position is based in our South San Francisco, CA location.

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