Senior Quality Engineer, Global Post Market - Intake

Job description

**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:** Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. The Senior Quality Engineer provides quality engineering support for manufacturing and product development, helping ensure the delivery of the highest-quality products to our patients. In this role, you will partner with cross-functional teams to improve manufacturing processes, strengthen quality systems and support the development of innovative medical technologies. As a senior technical contributor, you will lead quality initiatives across the product life cycle, influence process improvements and ensure compliance with global regulatory requirements. This position offers the opportunity to make a meaningful impact on patient safety while collaborating with teams across Engineering, Manufacturing, Operations and Quality. **Work model, sponsorship:** This position follows an on-site work model and requires employees to work from the local Boston Scientific office on a full-time basis. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. **Your responsibilities will include:** - Provide quality engineering support for manufacturing and new product development to ensure products meet customer, regulatory and business requirements. - Develop and implement product quality plans, product specifications, quality specifications, risk analyses and failure mode and effects analyses (FMEAs) in collaboration with cross-functional product development teams. - Serve as a subject matter expert for the complaint intake process within the global complaint handling system, supporting process execution, continuous improvement and regulatory compliance. - Monitor and evaluate global complaint records from multiple complaint sources and designated reporting locations to ensure timely and accurate event intake. - Lead or support global strategic quality initiatives as a project owner, subject matter expert or cross-functional team member. - Own and participate in nonconformance evaluations and corrective and preventive action (CAPA) activities to drive effective issue resolution and continuous improvement. - Develop quality tools, procedures and training materials that promote consistent application of quality system requirements and best practices. - Evaluate the effectiveness and compliance of quality systems, operations and manufacturing practices against applicable regulations and internal procedures. - Support internal and external audits, including serving as the quality representative during audit activities. - Apply analytical and systematic problem-solving methodologies to identify risks, investigate complex quality issues and implement sustainable solutions. - Partner with cross-functional teams to improve quality, reduce risk and drive operational excellence. - Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Boston Scientific Quality Policy and all documented quality system requirements. **Qualifications:** **Required qualifications:** - Minimum of a bachelor's degree in engineering, science or a related technical discipline. - Minimum of 5 years' experience in a regulated manufacturing industry. - Experience supporting quality systems, complaint handling, post-market surveillance or manufacturing quality within a regulated industry. - Experience leading or supporting corrective and preventive action (CAPA) investigations and root cause analysis. - Experience performing risk management activities, including risk analyses and failure mode and effects analyses (FMEAs). - Experience interpreting and applying quality system and regulatory requirements within a regulated industry. - Experience collaborating with cross-functional teams to support manufacturing, product development or quality improvement initiatives. **Preferred qualifications:** - Experience in the medical device industry. - Experience supporting new product development and design controls. - Experience leading cross-functional quality or continuous improvement projects. - Knowledge of statistical analysis tools, including Minitab and Microsoft Excel. - ASQ Certified Quality Engineer (CQE) or another relevant quality certification. - Demonstrated ability to influence cross-functional teams and lead technical initiative **Requisition ID: 631004** **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 [—](https://secure.bscbenefitsconnect.com/index.html)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 [](https://c212.net/c/link/?t=0&l=en&o=4007299-1&h=2437349916&u=https%3A%2F%2Fwww.bostonscientific.com%2F&a=www.bostonscientific.com) and follow us on [LinkedIn](https://www.linkedin.com/company/boston-scientific/). 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.