Senior Quality Engineer - Global Post Market Support
Boston Scientific | |
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4100 Hamline Avenue North (Show on map) | |
Apr 24, 2026 | |
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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. Here, you'll be supported in progressing - whatever your ambitions. About the role: 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: 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. Requisition ID:627626 Minimum Salary:$85000 Maximum Salary: $161500 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). 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 byprovidinga 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,neurologicaland urological diseases and conditions. Learn more atwww.bostonscientific.comand follow us onLinkedIn. 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 specificprohibited substancetest 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. | |
Apr 24, 2026