Senior Quality Systems Engineer - Bolt Integration

Senior Quality Systems Engineer

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, informationand training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

The Senior Quality Systems Engineer supports the Bolt Medical Acquisition Integration team. This role provides global process and quality system support, partnering with cross-functional stakeholders to maintain compliance, drive continuous improvement and ensure effective quality system integration and performance. The position contributes to the development, enhancement and integration of quality system processes and tools that support compliant product and information lifecycle management across the SEISMIQ product platforms and supporting sites.

This role follows a hybrid work model requiring employees to be in one of our local offices in MN, primarily Arbor Lakes or Arden Hills, MN at least three days per week.

Relocation assistance may be available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Integration Support
• Audit and Compliance
• Nonconformance & CAPA

What we're looking for in you:

Required qualifications:

• Bachelor's degree in Engineering, quality, life sciences or a related field
• 5 years' experience in quality systems within a regulated industry
• Working knowledge of regulations and standards applicable to the Boston Scientific Global Quality System and Document and Records Control processes, including ISO 13485, 21 CFR Part 820 and EU MDR.
• Demonstrated experience partnering with cross-functional stakeholders to support quality system processes
• Ability to travel up to 25%

Preferred qualifications:

• Proven experience supporting audits and inspections
• Prior experience with CAPA activities
• Integration experience
• Proven ability to influence without authority