Boston Scientific Sr Quality Engineer - Global Post Market Support 

United States, Minnesota 

425115897

Spencer Gregory Hale

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.

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.