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Senior Quality Engineer - Global Post Market Support

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Job Description - Senior Quality Engineer - Global Post Market Support

Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove\n\nDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance\n\nAt Boston Scientific, we\u2019ll give you the opportunity to harness all that\u2019s 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\u2019ll help you in advancing your skills and career. Here, you\u2019ll be supported in progressing \u2013 whatever your ambitions. \n\nAbout the role: \nBoston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.\n\nThis 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.\n\nWork model, sponsorship: \nAt 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. \n\nYour responsibilities will include:\n\n\u25cf Collaborate with divisional and global teams on complaint handling projects and corrective and preventive actions (CAPAs).\n\n\u25cf Support regulatory compliance through effective training, documentation and audit readiness activities.\n\n\u25cf 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.\n\n\u25cf 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.\n\n\u25cf Provide technical leadership to a network of global and divisional subject matter experts responsible for monitoring complaint handling processes.\n\n\u25cf Partner cross-functionally with complaint handling, risk management and IT/systems teams to ensure alignment and effectiveness.\n\n\u25cf Lead and support root cause investigations for recurring process failures and implement effective CAPAs.\n\n\u25cf Drive continuous improvement initiatives using quality engineering principles and critical thinking, ensuring alignment with regulatory requirements.\n\n\u25cf Define and establish process requirements based on customer needs, translating process outputs into actionable insights for downstream stakeholders.\n\nRequired qualifications:\n\n\u25cf Minimum of a bachelor\u2019s degree.\n\n\u25cf Minimum of 5 years\u0027 experience in quality within the medical device or pharmaceutical industry.\n\n\u25cf Strong understanding of post-market regulatory requirements.\n\nPreferred qualifications:\n\n\u25cf Demonstrated problem-solving, influencing and critical thinking skills.\n\n\u25cf Experience with project management methodologies and tools.\n\n\u25cf Experience working in a global or multi-divisional environment.\n\n\u25cf Experience with statistical process control (SPC) and other statistical tools for quality data analysis, including application to business processes.\n\n\u25cf ASQ Certified Quality Engineer (CQE), Lean Six Sigma or similar certification.\n\n\u25cf Working knowledge of medical device regulations, including EU MDR, ISO 13485 and ISO 14971.\n\nRequisition ID: 627626\n\nMinimum Salary: $ 85000\n\nMaximum Salary: $ 161500\n\nThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) \u2013 see www.bscbenefitsconnect.com\u2014will 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.\n\nCompensation 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).\n\nCompensation 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).\n\nFor MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.\n\nBoston 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.\n\nBoston 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.\n\nPlease 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\u2019s policies or protocols change with regard to COVID-19 vaccination.\n\nAmong 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. \n
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