Senior Quality Systems Engineer

Job Summary 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. Work Model and Relocation Hybrid work model requiring at least three days per week in Marlborough, MA or Arden Hills, MN or Maple Grove, MN. The company does not offer visa sponsorship or relocation assistance for this position. Responsibilities 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. Required Qualifications Minimum of a 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 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 openness to learning digital product ownership, quality systems application support and/or IT project experience. Preferred Qualifications Medical device industry experience preferred. Prior document control and records management experience preferred. Proven experience supporting audits, inspections and CAPA activities. Compensation Minimum Salary: $89,200; Maximum Salary: $169,500. The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific will vary based on the 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. For MA positions it is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Benefits 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). Additional Information For safety‑sensitive positions, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with applicable law. Certain U.S. based positions, including field sales and service roles 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 Corporation is an equal opportunity employer. The Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Nearest Major Market: Boston Job Segment: Compliance, Senior Quality Engineer, Medical Device Engineer, Risk Management, Systems Engineer, Legal, Engineering, Finance #J-18808-Ljbffr Boston Scientific Gruppe