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.
The Quality Engineer III provides focused quality engineering support within the Urology RCPH manufacturing core team in Spencer, Indiana. This role develops, establishes and maintains quality engineering methodologies, systems and practices that meet Boston Scientific, customer and regulatory requirements.
Serving as a quality representative, this role improves awareness, visibility and communication of quality initiatives while supporting departmental, functional, site, divisional and corporate quality goals and priorities. The Quality Engineer partners across manufacturing, engineering, product, supplier and divisional teams to advance patient safety, product quality, operational excellence and continuous improvement.
Work model, sponsorship, relocation:
This is an on-site role based in Spencer, Indiana. Relocation assistance is not available for this position at this time.
Your responsibilities will include:
- Provide focused quality engineering support for manufacturing operations and system/service support for Spencer RCPH (Retrievals, Catheters, Pelvic Health), partnering with Urology, PI IO&E, Endoscopy, CRM Cardiac and other Boston Scientific sites and divisions.
- Provide manufacturing line support and monitor product quality to ensure compliance with established requirements.
- Identify nonconformance events and initiate, own and complete NCEP records.
- Determine and execute appropriate product and process containment associated with NCEP events.
- Escalate CAPAs when appropriate and own and complete CAPA records.
- Determine the scope of product impact during PIR ET, PIR and field action scenarios.
- Partner with manufacturing engineers and product supervisors to provide leadership within the manufacturing core team.
- Drive lean production and system processes and deliver measurable value through the VIP system.
- Advance Protect the Core, Guardian and Delivering Excellence strategic goals, including complaint reduction, Quality Catch mitigations, workstation vulnerability score reduction, IPM improvement and preventive CAPAs.
- Partner with cross-functional core team members and share ownership of deliverables related to PCA, new products, acquisition products, DCA product support, supplier engineering and supplier quality.
- Collaborate with divisional Design Quality and R&D partners, serving as an internal voice of the customer across Urology, PI IO&E, Endoscopy, CRM Cardiac and other Boston Scientific sites and divisions.
- Champion departmental and cross-functional engineering initiatives and serve as an effective leader or team member in supporting quality disciplines, decisions and practices.
- Provide project direction, coaching and mentoring to engineering and technical team personnel.
- Proactively investigate, identify and implement best-in-class quality engineering practices.
- Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues, including associated risk documentation.
- Review and approve product, process and equipment qualification and validation documentation, as well as other change-control documentation.
- Generate internal quality documentation, including NCEP, CAPA, PIR ET and CAPA ET records; PTP and QSDP quality plans; and SOP, WI, GOI and KSD procedures.
- Ensure compliance with Boston Scientific regulatory requirements, FDA requirements and applicable ISO standards across areas of responsibility.
- Identify nonconformance trends in QSIG or IPM and develop technical investigation plans.
- Investigate and analyze customer and internal complaints in support of the CIS lab.
- Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Boston Scientific Quality Policy and all documented quality processes and procedures.
- Use sound judgment to solve problems and determine appropriate actions and solutions within applicable requirements, guidelines and policies.
- Organize, present and explain data and information effectively, primarily to internal audiences.
- Provide coaching and mentorship to team members and peers as appropriate while remaining accountable for individual contributions and objectives.
Qualifications:
Required qualifications:
- Bachelor’s degree in engineering or a related technical discipline.
- Demonstrated knowledge of quality engineering principles, methodologies, systems and practices within a regulated environment.
- Working knowledge of business and industry practices and organizational processes.
- Experience applying structured problem-solving methodologies to investigate and resolve quality issues.
- Experience supporting nonconformance investigations, containment activities and corrective and preventive actions.
- Experience reviewing or supporting product, process or equipment qualification and validation documentation.
- Ability to interpret, organize and communicate technical data and information effectively.
- Ability to exercise independent judgment and determine appropriate solutions while working within established quality and regulatory requirements.
- Ability to collaborate effectively with manufacturing, engineering, quality and other cross-functional partners.
Preferred qualifications:
- Experience in medical device manufacturing or another highly regulated industry.
- Experience with FDA regulations, ISO standards and quality system requirements.
- Experience with NCEP, CAPA, PIR, complaint investigation or related quality processes.
- Experience supporting manufacturing operations and product quality within a cross-functional core team.
- Experience with lean manufacturing, continuous improvement or value improvement initiatives.
- Experience coaching or mentoring engineering or technical team members.
Requisition ID: 632647
Minimum Salary: $ 74600
Maximum Salary: $ 141700
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 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.
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.
