SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. The Quality Engineer/Sr. Quality Engineer will support the Quality Department in ensuring compliance with federal law and applicable standards.
Requirements
- Investigate and review SI-BONE medical device complaints
- Write protocols and reports for activities such as sterilization validation, cleaning validation, biocompatibility testing, and packaging validation
- Support New Product Development activities
- Develop requirements for sterilization and monitoring of sterilization and endotoxins for new products
- Assist the Quality team daily to accomplish efficient and effective review and approval of records
- Monitor and ensure compliance to internal quality system and external industry regulations
- Perform activities pertaining to supplier audits
- Handle supplier changes and work with Engineering and other departments as appropriate 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 direction 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 Regulatory Affairs and Engineering personnel in new product/process design to assure effective control procedures are established
- Support internal/external audits to assess compliance to standards and to the internal QMS
- Assist in development, maintenance, and reporting of department metrics
- Develop/update hazard analyses and FMEAs
- Support the management of eQMS systems including MasterControl
Benefits
- bonus
- stock
- Generous Paid Time Off
