Senior Quality Systems Engineer

Boston Scientific • Arden Hills, MN

4d • $85,000 - $161,500 • Hybrid

About The Position

The Senior Quality Systems Engineer serves as a highly experienced Quality Systems and systems engineering resource supporting critical quality system initiatives across the Arden Hills site and partnering divisions. This role provides technical leadership and project execution for complex compliance challenges, Quality System remediation activities, audit readiness, Corrective and Preventive Action (CAPA), regulatory inspections and cross-functional quality improvement initiatives. The Senior Quality Systems Engineer operates as a flexible shared resource capable of leading or supporting high-priority business needs requiring deep Quality System expertise, strong project management skills and the ability to navigate complex organizational and regulatory environments. This individual partners with Quality, Regulatory, Manufacturing, Operations, Research and Development (R&D), Supply Chain and divisional leadership to solve challenging compliance issues while ensuring the Quality System remains suitable, effective and compliant with global regulatory requirements. This position independently assesses business needs, prioritizes competing demands, leads cross-functional teams and executes projects that improve compliance, reduce organizational risk and strengthen overall Quality System performance.

Requirements

• Bachelor's degree in Engineering, Science, Quality or a related technical discipline with a minimum of 5 years' experience, or a master's degree with a minimum of 3 years' experience, preferably within the medical device industry.
• Demonstrated experience leading complex Quality System projects involving multiple functional organizations.
• Comprehensive knowledge of global medical device regulations, including 21 CFR Part 820/Quality Management System Regulation (QMSR), ISO 13485, EU MDR, MDSAP, ISO 14971 and other applicable regulatory requirements.
• Strong understanding of CAPA systems, quality investigations, audit processes and Quality System compliance.
• Experience leading or supporting regulatory inspections, notified body audits, customer audits or internal audits.
• Excellent project management, communication, facilitation and stakeholder management skills.
• Ability to analyze complex compliance issues and develop practical, sustainable solutions.
• Ability to work independently while influencing without direct authority.
• Demonstrated ability to remain effective and decisive during high-pressure situations.

Nice To Haves

• Experience supporting external inspections, including FDA, Competent Authority, notified body, MDSAP or other international regulatory inspections.
• Experience leading complex CAPA, compliance remediation or Quality System improvement projects.
• Experience supporting Product Investigation Reports (PIRs), field actions or quality and compliance initiatives.
• Lean Six Sigma certification, ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA) or an equivalent professional certification.
• Experience serving as a Quality Systems subject matter expert across multiple Quality System processes.
• Demonstrated success leading cross-functional teams through complex organizational challenges.
• Experience within medical device manufacturing in a highly regulated environment.

Responsibilities

• Lead or support complex Quality System compliance initiatives and cross-functional remediation projects across the Arden Hills site.
• Serve as a Quality Systems subject matter expert for complex compliance issues, regulatory expectations and Quality System implementation.
• Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate and resolve complex Quality System issues.
• Lead and support CAPA system activities, including investigation quality, effectiveness reviews, documentation improvements, aging reduction initiatives and cross-functional execution.
• Assist with the development and maintenance of department metrics and management systems, as needed.
• Act as an effective leader and collaborative team member in Quality System activities supporting strategic compliance initiatives, goals and objectives.
• Support external audits through preparation, execution, coordination, evidence collection, response development and closure activities for regulatory inspections and third-party audits.
• Partner with Quality System process owners to identify compliance gaps and implement sustainable corrective actions.
• Support organizational readiness for regulatory inspections through proactive assessments, coaching and continuous improvement activities.
• Identify opportunities to simplify, standardize and improve Quality System processes while maintaining compliance.
• Promote a work environment that supports the Global Quality Policy, Global Quality System, continuous improvement and Winning Spirit.

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