Boston Scientific is looking to improve supplier performance and capabilities to consistently meet their requirements, and to support global sourcing, manufacturing operations, and global quality systems.
Requirements
- Experience in process validation, design controls, risk management, and CAPA.
- Experience in medical device and medical device suppliers.
- Experience with quality systems and processes.
- Experience as lead auditor of quality systems (ISO13485 or similar)
- ASQ certification (CQE, CBA, SSGB, SSBB).
Responsibilities
- Evaluates supplier caused manufacturing yield issues, incoming quality issues, and field failures and applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving the issues.
- Monitors supplier performance to drive improvement and corrective action in the quality of components sourced from outside suppliers.
- Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
- Assess suppliers for technical, quality and manufacturing capabilities through direct on-site visits and technical discussions.
- Assists in the evaluation of proposed changes at suppliers.
- Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
- Develops and maintains incoming acceptance methods for materials and trains incoming inspectors to procedures.
Other
- BS degree in electrical, mechanical, or biomedical engineering or related engineering with minimum of 5 years of relevant experience.
- Project management experience, ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing.
- Ability to work independently; organized and self-driven.
- Strong communicator; adept at packaging and appropriately scaling information to the intended audience.
- Domestic and international travel up to 20%.
