Senior Quality Assurance Manager

Additional Location(s): N/A\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\n \n\nAbout the role: \nBoston 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.\n\nThe Senior Quality Assurance Manager provides leadership for site sterilization release activities in Coventry, Rhode Island. This role partners closely with the Quality Systems Manager to develop, implement, coordinate and monitor quality systems that ensure compliance with all regulatory and company requirements. As a key member of the site leadership team, this position drives continuous improvement, supports daily operations and ensures product quality and patient safety across sterilization processes.\n\n \n\nWork model, sponsorship, relocation: \nThis role is on-site in Coventry, Rhode Island. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. \n\n \n\nYour responsibilities will include:\n\n\u25cf Lead sterilization release activities and ensure compliance with all quality system requirements and regulatory standards.\n\n\u25cf Manage the day-to-day operations of the Quality Assurance team, including quality engineers and technicians.\n\n\u25cf Maintain and improve quality systems, including process validation, process control, nonconformance management and CAPA systems.\n\n\u25cf Support daily site operations and sterility processing, providing expertise in quality and sterilization-related issues.\n\n\u25cf Provide guidance, consultation and problem-solving support to address quality and operational challenges.\n\n\u25cf Direct workforce planning, hiring, performance management, training compliance and professional development of team members.\n\n\u25cf Coach and advise supervisors, group leaders and staff on technical and operational matters.\n\n\u25cf Design and implement inspection and testing methods; conduct quality assurance testing and statistical analysis.\n\n\u25cf Facilitate global sterility release of products through collaboration with corporate sterility teams.\n\n\u25cf Ensure compliance with FDA, ISO 13485, ISO 11135 and all applicable federal, state and international regulations.\n\n\u25cf Contribute to quality organization design and support development of long-term quality objectives and strategies.\n\n\u25cf Promote a culture of continuous improvement, patient safety and adherence to the Boston Scientific Quality Policy.\n\n\u25cf Ensure adequate resources, tools and systems are in place to maintain quality system compliance.\n\n\u25cf Perform additional responsibilities as required.\n\n \n\nQualifications:\n\nRequired qualifications:\n\n\u25cf Bachelor\u2019s degree in engineering, life sciences or a related field\n\n\u25cf Minimum of 7 years\u0027 experience in quality assurance within a regulated industry\n\n\u25cf Minimum of 3 years\u0027 experience in a leadership or people management role\n\n\u25cf Experience with sterilization processes and sterility assurance\n\n\u25cf Strong knowledge of FDA regulations, ISO 13485 and ISO 11135\n\n\u25cf Experience with CAPA, nonconformance systems and process validation\n\n\u25cf Demonstrated ability to lead teams and drive continuous improvement initiatives\n\n\u25cf Strong problem-solving, analytical and decision-making skills\n\n\u25cf Excellent communication and stakeholder management skills\n\nPreferred qualifications:\n\n\u25cf Advanced degree in engineering, science or a related discipline\n\n\u25cf Experience in the medical device industry\n\n\u25cf Experience working with global quality or sterilization teams\n\n\u25cf Certification in quality (e.g., ASQ CQE, CQM)\n\n\u25cf Experience supporting audits and regulatory inspections\n\n \n\nRequisition ID: 627635\n\nMinimum Salary: $ 131700\n\nMaximum Salary: $ 250200\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