Senior Quality Engineer - Combination Product

Job description

**Additional Location(s):** N/A **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. Boston 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. At this time, we are seeking a Senior Quality Engineer to support the manufacturing of combination products. In this role, you will partner with Operations and Product Development teams to ensure compliance with current Good Manufacturing Practice (cGMP) requirements for combination products while delivering innovative, high-quality drug-device combination therapies for patients. This position directly supports the Arden Hills Operations business unit manufacturing Urology combination products and offers opportunities to collaborate across additional business units, product portfolios, and divisions. **Work model, sponsorship, relocation:** At Boston Scientific, we value collaboration and innovation. This position follows an on-site work model and requires employees to work from the Arden Hills facility five days per Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Relocation assistance is not available for this position at this time. **Your responsibilities will include:** ● Lead compliance and continuous improvement initiatives supporting the manufacture of combination products in accordance with 21 CFR Part 4. ● Serve as the technical quality lead during internal and external audits related to combination product compliance. ● Analyze quality data to identify trends, drive continuous improvement initiatives, and implement effective corrective and preventive actions. ● Develop quality tools and training materials while effectively communicating requirements across a broad range of organizational skill levels. ● Lead cross-functional teams to reduce manufacturing defects, including scrap, nonconforming product and customer complaints, through root cause analysis and corrective actions. ● Support product containment activities, including product stops and release criteria documentation, as required. ● Develop and implement product quality plans, specifications, risk analyses and Failure Modes and Effects Analyses (FMEAs) in partnership with Product Development and Manufacturing teams. ● Develop process monitoring systems by identifying critical manufacturing process steps, reducing process variation and improving process capability. ● Collect, analyze and interpret manufacturing quality metrics to support sustaining product improvements and new product development initiatives. ● Evaluate the effectiveness and compliance of quality systems, manufacturing operations and business practices against applicable regulations and internal procedures. ● Perform internal quality audits, as assigned, and support continuous improvement of the Boston Scientific Quality System. **Required qualifications:** ● Minimum Bachelor's degree in Chemical Engineering, Chemistry or a related scientific or engineering discipline. ● Minimum of 5 years' experience in manufacturing, quality engineering, regulatory or a related regulated industry. ● Minimum of 2 years' experience supporting regulated cGMP environments involving combination products (21 CFR Part 4) and/or pharmaceutical manufacturing (21 CFR Parts 210 and 211). ● Demonstrated experience supporting cGMP compliance for drug-device combination products or pharmaceutical manufacturing. ● Proven knowledge of statistical analysis methods and proficiency with Microsoft Excel and Minitab. ● Demonstrated experience supporting internal and external quality audits. **Preferred qualifications:** ● Minimum of 7 years' experience in manufacturing, quality or regulatory functions. ● Minimum of 2 years' experience providing technical leadership. ● Experience managing multiple cross-functional projects simultaneously. ● Recent or current experience serving as a technical lead during external regulatory audits. ● Demonstrated commitment to proactive quality, regulatory compliance and continuous improvement. **Requisition ID: 619126** **Minimum Salary: $ 82600** **Maximum Salary: $ 156900** 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. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 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.