Quality Engineer, CAPA

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 is seeking an experienced and strategic Quality Engineer to serve as the CAPA program owner and drive continuous improvement across the organization. This high-impact role will lead root cause investigations, implement effective corrective and preventive actions (CAPAs), and ensure compliance with regulatory and quality standards. You’ll collaborate cross-functionally and influence process enhancements that strengthen our Quality Management System.

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston 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:

● Serve as the CAPA program owner, managing all phases of the CAPA lifecycle from initiation to closure.

● Lead or support complex root cause investigations using structured problem-solving tools such as 5 Whys, Fishbone diagrams, 8D, and FMEA.

● Facilitate cross-functional teams to identify, analyze, and eliminate root causes of quality issues.

● Partner with Engineering, Manufacturing, Regulatory, and Operations to develop and implement robust corrective and preventive actions.

● Monitor CAPA effectiveness, track metrics, and identify quality trends and opportunities for improvement.

● Ensure CAPA documentation complies with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other applicable regulatory standards.

● Support internal and external audits by providing CAPA documentation and participating in audit activities.

● Assist with training team members on CAPA processes and quality system requirements.

● Contribute to ongoing continuous improvement efforts and quality system enhancements.

● Perform other duties as assigned.

Qualifications:

Required qualifications:

● Bachelor’s degree in Engineering, Life Sciences, or a related field.

● Minimum of 5 years' experience in Quality Engineering, preferably in a regulated industry (e.g., medical devices or pharmaceuticals).

● Proven experience managing CAPA processes and leading root cause investigations.

● Strong understanding of regulatory requirements including FDA QSR, ISO 13485, ISO 14971, and EU MDR.

● Proficiency with quality tools and methodologies such as Six Sigma, Lean, and Kaizen.

● Experience with electronic Quality Management Systems (eQMS), such as TrackWise or similar platforms.

● Excellent communication, documentation, and project management skills.

Preferred qualifications:

● Certified Quality Engineer (CQE), Six Sigma Green or Black Belt, or similar certification.

● Experience in complaint handling, nonconformance investigations, and post-market surveillance.

Requisition ID: 618962 

Minimum Salary: $ 61000 

Maximum Salary: $ 115900 

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.

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.