Senior Quality Systems Engineer

Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove

Diversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance

Work model, sponsorship, and relocation:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office Marlborough, MA or Arden Hills, MN or Maple Grove, MN at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

• Execute assigned process ownership responsibilities within a global governance framework while collaborating with global process stewards who provide compliance oversight.
• Support standardization efforts and maintain audit readiness in accordance with applicable regulations and standards, including ISO 13485, 21 CFR Part 820 and EU MDR.
• Participate in process monitoring, documentation updates, regulatory implementation activities and issue resolution to maintain a permanent state of compliance.

• Serve as a quality systems subject matter expert and business partner for digital platforms supporting document and records control processes.
• Collaborate with IT and cross-functional stakeholders to support system configuration, enhancements, issue resolution and lifecycle management activities.
• Partner with IT to translate business and regulatory requirements into technical solutions, validation activities and testing strategies.
• Support root cause investigations, incident management and timely resolution of system-related issues to minimize business disruption.

• Lead continuous improvement initiatives using structured methodologies, including VIP, to drive efficiency, scalability and operational excellence.
• Identify, analyze and resolve quality system issues using systematic problem-solving methodologies.
• Drive process enhancements that strengthen quality culture and improve overall system effectiveness.

• Serve as an owner or lead contributor for nonconformance, exception and CAPA activities.
• Support root cause analysis, corrective and preventive action planning, implementation and effectiveness verification.
• Contribute to risk management activities and systemic issue resolution efforts.

• Lead or support complex global quality system projects, including process implementations, business transfers and acquisition integrations.
• Contribute to the global quality systems roadmap and support alignment with organizational commitments and priorities.
• Participate in and lead Communities of Practice activities to promote standardization and adoption of best practices.

• Serve as an audit-facing subject matter expert for assigned quality processes and digital quality systems.
• 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.

• Mentor and support Quality Systems Engineers while contributing to team capability development.
• Deliver training on quality system processes, digital tools and applicable regulatory requirements.
• Support broader departmental and Quality Systems initiatives as business needs require.

• Minimum of Bachelor's degree in Engineering, quality, life sciences or a related field.
• Minimum 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 and digital tools.
• Previous experience or open to learning digital product ownership, quality systems application support and/or IT project experience.

• Medical device industry experience preferred.
• Prior document control and records management experience preferred.
• Proven experience supporting audits, inspections and CAPA activities.

Requisition

Minimum Salary: $89,200

Maximum Salary: $169,500

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the…