Senior Quality Engineer - Global Post Market Support

Senior Quality Engineer - Global Post Market Support

Work mode: Hybrid Onsite Location(s): Arden Hills, MN, US, 55112 Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At 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.

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. This global role is responsible for developing and maintaining standardized complaint handling processes for post-market support teams across all Boston Scientific divisions. You will partner with global and divisional stakeholders to drive regulatory compliance, operational excellence and continuous improvement across complaint handling systems and processes.

Work model, sponsorship: At Boston Scientific, we value collaboration and synergy. This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills, MN, Maple Grove, MN or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include: Collaborate with divisional and global teams on complaint handling projects and corrective and preventive actions (CAPAs). Support regulatory compliance through effective training, documentation and audit readiness activities. Evaluate the adequacy and compliance of systems, operations and practices against regulatory requirements and internal procedures; serve as a subject matter expert during internal and external audits. Coordinate with global and divisional teams to develop and maintain clear documentation, including standard operating procedures (SOPs), work instructions and control plans to ensure consistency and compliance. Provide technical leadership to a network of global and divisional subject matter experts responsible for monitoring complaint handling processes. Partner cross-functionally with complaint handling, risk management and IT/systems teams to ensure alignment and effectiveness. Lead and support root cause investigations for recurring process failures and implement effective CAPAs. Drive continuous improvement initiatives using quality engineering principles and critical thinking, ensuring alignment with regulatory requirements. Define and establish process requirements based on customer needs, translating process outputs into actionable insights for downstream stakeholders.

Required qualifications: Minimum of a bachelor's degree. Minimum of 5 years' experience in quality within the medical device or pharmaceutical industry. Strong understanding of post-market regulatory requirements.

Preferred qualifications: Demonstrated problem-solving, influencing and critical thinking skills. Experience with project management methodologies and tools. Experience working in a global or multi-divisional environment. Experience with statistical process control (SPC) and other statistical tools for quality data analysis, including application to business processes. ASQ Certified Quality Engineer (CQE), Lean Six Sigma or similar certification. Working knowledge of medical device regulations, including EU MDR, ISO 13485 and ISO 14971.

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see 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.

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.

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.