Senior Quality Systems Engineer - Bolt Integration

Boston Scientific•Arden Hills, MN

7d•$85,000 - $161,500•Hybrid

About The Position

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.

Requirements

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%

Nice To Haves

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

Responsibilities

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.
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.
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.