Senior Quality Systems Engineer

Boston Scientific; Arden Hills (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific in Arden Hills, MN seeks a Senior Quality Systems Engineer to lead complex quality system initiatives across the site and partner divisions. You will apply CAPA, audit readiness, and regulatory inspections support, driving cross-functional remediation and continuous improvement.

You'll mentor teams, manage CAPA investigations, and develop metrics to strengthen overall quality performance in a highly regulated medical device environment.

Qualifications

• Bachelor's degree in Engineering, Science, Quality or a related technical discipline.
• Masters degree with 3+ years of relevant experience preferred in medical device industry.

Responsibilities

• Lead or support complex Quality System compliance initiatives and cross-functional remediation at the Arden Hills site.
• Serve as a Quality Systems expert for complex compliance issues and regulatory expectations.
• Lead and support CAPA system activities including investigations, effectiveness reviews and documentation improvements.
• Assist in development and maintenance of department metrics and management systems.
• Support external audits, regulatory inspections, and third-party audits with evidence collection and response.

Education

Bachelor's degree in Engineering/Science/Quality

Master's degree

Job description

Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.About the role:Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.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.Work model, sponsorship, relocation:At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office 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.Your responsibilities will include: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.Qualifications:Required qualifications: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.Preferred qualifications: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.Requisition ID: 632315Minimum Salary: $ 85000Maximum Salary: $ 161500The 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).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.Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, 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.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 COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, 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 the applicable law.