Senior Quality Systems Engineer - Bolt Integration

Senior Quality Systems Engineer
- Bolt Integration

Work mode:
Hybrid Onsite Location(s):
Maple Grove, MN, US, 55311 Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills Diversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance 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, information and training, we'll help you in advancing your skills and career.

About the role:

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.

Work mode:
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:
Relocation assistance may be available for this position at this time. Visa sponsorship:
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
• Support integration of legacy processes and products into the BSC quality system.
• Own and drive deliverables associated to integration execution in alignment with the global quality systems roadmap and overall program priorities.
• Participate in and lead Communities of Practice activities to promote standardization and adoption of best practices.
• Lead or support continuous improvement initiatives using structured methodologies to drive efficiency, scalability and operational excellence.
• Identify, analyze and resolve quality system issues using systematic problem-solving methodologies. Audit and Compliance
• Support standardization efforts and maintain audit readiness in accordance with applicable regulations and standards, including ISO 13485, 21 CFR Part 820 and EU MDR.
• Support external audits and regulatory inspections through preparation, execution, back-room support and follow-up activities.
• Develop training materials, audit support documentation and related compliance resources.
• Serve as an audit-facing subject matter expert for assigned quality processes and digital quality systems.
• Ensure compliance to external standards and regulations through the integration process, including maintenance of supporting documentation. Nonconformance & CAPA
• Serve as an owner or lead contributor for nonconformance, exception and CAPA activities.
• Serve as CAPA mentor.
• Contribute to risk management activities and systemic issue resolution efforts. 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