Sr Quality Engineer - Global Post Market Support

Sr Quality Engineer - Global Post Market Support

Work mode: Hybrid

Onsite Location(s): Arden Hills, MN, US, 55112

About the role:

This global position focuses on developing and maintaining standardized training for post-market support teams across all divisions within Boston Scientific. This role will collaborate with both divisional and global teams to ensure consistent documentation and training practices, supporting regulatory compliance and operational excellence.

Your responsibilities will include:

• 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. May be responsible for risk analyses and FMEAs.
• 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. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.

What we're looking for in you:

Minimum Qualifications

• Minimum bachelor's degree.
• Minimum of 5 years of quality experience in a medical device or pharmaceutical industry.
• Strong understanding of post-market regulations.
• Excellent problem-solving, influencing, and critical thinking skills.
• Ability to work a hybrid (3 days in office/2 days remote) schedule.

Preferred Qualifications

• Project management skills.
• Experience working in a global or multi-division environment.

Nearest Major Market: Minneapolis

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