Boston Scientific is looking to standardize training for post-market support teams across all divisions globally to ensure consistent documentation and training practices, supporting regulatory compliance and operational excellence.
Requirements
- Minimum of 5 years of quality experience in a medical device or pharmaceutical industry.
- Strong understanding of post-market regulations.
- Develop and implement product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analysis, FMEAs in conjunction with other product development team members.
- Develop and implement Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
- Collect and analyze Leads Manufacturing process defect data Product/Process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development
- Create Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
- Evaluate the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
Responsibilities
- Develop and maintain global training programs for post-market support teams.
- Collaborate with divisional and global teams to standardize training and documentation.
- Ensure proper training is delivered outside of standard learning platforms.
- Support regulatory compliance through effective training and documentation practices.
- Develop and implement product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analysis, FMEAs in conjunction with other product development team members.
- Develop and implement Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
- Collect and analyze Leads Manufacturing process defect data Product/Process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development
Other
- Minimum bachelor’s degree.
- Excellent problem-solving, influencing, and critical thinking skills.
- Ability to work a hybrid (3 days in office/2 days remote) schedule.
- Project management skills.
- Experience working in a global or multi-division environment.
