SetPoint Medical is seeking an experienced quality engineer to work collaboratively in a cross-functional environment to ensure the delivery of high-quality development projects within approved program schedules. The Senior Quality Engineer will be responsible for the generation and review of all design control and risk management activities.
All candidates will be asked to describe in detail their individual as well as team contributions towards development and testing activities within a Class II/III medical device environment.
- Provide functional input during development project planning to accurately assess resource and scheduling considerations
- Partner with Product Development and other cross-functional team members to define design input (i.e. Customer, System, Hardware, Software Requirements)
- Review and approve design input and design output documentation
- Partner with Product Development, other cross-functional team members and consultants/external test houses to define design verification and validation testing
- Assist in the execution of dry runs and in oversight of official V&V testing
- Review and approve verification and validation test plans and test reports
- Represent as lead quality assurance team member in design review and phase review meetings
- Drive project/system level risk management deliverables (i.e. plans, Device Hazard Analyses, reports, and Risk Management)
- Review and approve other cross-functionally developed risk management deliverables(i.e. uFMEA, pFMEA)
- Review, assess, and approve all proposed changes (i.e. Engineering Change Orders, Deviations, etc.) to ensure proper level of testing supports implementation
- Verify development project documentation is in compliance with Company procedures
- Current working knowledge of 21 CFR Part 820 (QSR), ISO 13485, ISO 14971, and other standards as required
- Other projects as assigned