The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is looking to improve supplier manufacturing processes to ensure patient safety and continually improve the quality of finished devices.
Requirements
- Experience in process validation, design controls, risk management, CAPA, SCAR.
- Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
- Lead auditor of quality systems experience (ISO 13485 or similar).
- ASQ certification (CQE, CBA, SSGB, SSBB) desired.
- Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
- Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
- Knowledge of quality systems and regulations (e.g., ISO 13485)
Responsibilities
- Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues.
- Proactively assesses supplier capabilities through direct on-site visits and technical discussions.
- Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements.
- Manages sustaining quality issues, process change impacts, and design change implementations in the BSC Quality System.
- Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
- Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
- Investigates complaints and manages NCEPs at OEM suppliers where the issue is manufacturing-related.
Other
- BS degree in engineering or technical field with minimum of 2 years of relevant experience in quality engineering.
- Domestic and international travel up to 25%.
- Organized and self-driven.
- Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
- Ability to work in a team environment and collaborate with cross-functional teams.
