Senior Quality Systems Engineer

bostonscientific • Maple Grove, MN

2d • Hybrid

About The Position

The Senior Quality Systems Engineer supports the Global Quality Systems and Acquisition Integration team within the Document and Records Control function. This role provides global process and digital system support, partnering with IT and cross-functional stakeholders to maintain compliance, drive continuous improvement and ensure effective quality system performance. The position contributes to the development, maintenance and enhancement of quality system processes and tools that support compliant information lifecycle management across Boston Scientific. 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.

Requirements

• 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

Nice To Haves

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

Responsibilities

• Global quality process and compliance ownership: 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.
• Digital quality systems and IT partnership: 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.
• Continuous improvement and operational excellence: 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.
• Quality events, CAPA and risk management: 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.
• Project leadership and global collaboration: 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.
• Audit and regulatory support: 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.
• Leadership, mentorship and training: 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.

Benefits

• The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com— will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.
• Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
• At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
• Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior