Associate Quality Engineer

SI‑BONE is a fast‑growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy.

Location:

Santa Clara, CA. Must be onsite 5 days a week.

• Provide Quality Department support for SI‑BONE products, ensuring that our actions result in meeting our customer needs while maintaining compliance with federal law and applicable standards.
• Perform all duties in compliance with all applicable worldwide regulatory requirements as included in the scope of the SI‑BONE Quality Manual.
• Investigate and review SI‑BONE medical device complaints in conjunction with Regulatory Affairs.
• Act and conduct company business in an honest, ethical and lawful manner, consistent with the company’s Code of Conduct, other company policies and the Adva Med Code of Conduct and/or any other applicable industry code(s) of conduct. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

• Investigate and review SI‑BONE medical device complaints to identify root causes, solutions, and trends.
• Write protocols and reports for activities such as sterilization validation, cleaning validation, biocompatibility testing, and packaging validation for new product development.
• Support new product development activities, including assessment and characterization of design, process, and use risks, design verification and validation (V&V) testing.
• Develop requirements for sterilization and monitoring of sterilization and endotoxins for new products.
• Support and write reports for real‑time and accelerated shelf‑life testing as part of packaging validation of new products.
• Write system requirement specifications, risk analyses, software validation protocols and reports, and traceability matrices.
• Advise the manager of factors that may affect product quality, initiate reports for deviations and non‑conforming materials, and provide guidance/options and ideas for corrective actions and preventive actions (CAPA).
• Perform quality role for sustaining engineering, new product development, design change (DC) projects and non‑standard products (NSPs).
• Assist the quality team daily to accomplish efficient and effective review and approval of records as assigned, including calibration and maintenance work, procedures, validation protocols, validation reports, deviations and change controls.
• Monitor and ensure compliance with internal quality system and external industry regulations.
• Perform activities pertaining to supplier audits, including audit plans, audit execution, audit reports.
• Handle supplier changes and work with engineering and other departments to implement changes in standard operating procedures.
• Develop and maintain inspection and quality control procedures.
• Provide direction in developing supplier and incoming inspection plans, sampling plans, inspection, and acceptance criteria for new products.
• Provide directions for supplier controls for new products, DCs, and NSPs, including performing vendor audits and evaluations.
• Help handle and maintain ASL for new products, DCs, and NSPs, and support sustaining suppliers as required.
• Support CAPAs, NMRs, deviations, extension/scope changes for new, sustaining products, DCs, and NSPs.
• Assist in developing and improving departmental procedures and other controlled documents.
• Evaluate adequacy of specifications for new or modified process designs.
• Participate in process and technical design reviews and design reviews that are part of five‑phase device development.
• Develop, review, and approve process and equipment validations/qualifications for sustaining, new product development and DC applications.
• Perform new product process evaluations, including process capability studies, to identify areas for improvement and to reduce variability and lower total quality costs.
• Assist…