- Be a part of the sustaining project team and work in the design quality engineering across the entire product cycle.
- Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g.
Project
Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable)
- Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts (if required) for commercial products.
- Manage electronic document control and version control on all project-related documents.
- Ensure adherence to the quality systems, design assurance SOPs, and Boston Scientific’s PLCP.
- Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country-specific compliance with the laws and regulations of the targeted market for distribution.
- Lead in implementing assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.