Principal Quality Systems Engineer

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 This Role: The Principal Quality Systems Engineer (CAPA Mentor) will be primarily responsible for supporting the Global Capital Equipment (GCE) CAPA team and serve as an SME for the GCE CAPA portfolio. This role will provide mentoring support and guidance in the management of CAPA and NCEP to ensure compliance to internal procedures and global regulatory requirements.

The candidate will partner with NCEP and CAPA owners and cross functional teams to drive meaningful and robust solutions and corrective actions. They will also participate in CAPA Pillar communities of practice and partner with Global CAPA steward to maintain and improve the related processes and system to support capital equipment portfolio. They will also ensure appropriate quality system processes are maintained and followed in support of CE quality objectives.

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.

Relocation assistance is not available for this position at this time.

Your responsibilities will include:

Functional Knowledge

• Provides guidance to GCE CAPA portfolio management ensuring a high-quality standard and in line with applicable Management Review metrics.
• Acts as a CAPA mentor for corrective actions necessary to improve the global CAPA, NCEP and PIR processes as appliable.
• Guide NCEP and CAPA teams, from a technical perspective, through risk assessment, correction, structured root cause analysis and corrective actions.
• Remains current on all quality systems regulations for all regulatory agencies related to the CAPA Pillar.

Leadership/Mentorship

• Mentors Capital Equipment CAPA, NCEP and PIR Stewards to create and champion improvement in the CAPA Pillar and all related SOP’s and business processes.
• Acts as a resource and mentor for colleagues with less experience
• Support and potentially lead Service Quality internal audits as needed. Provide guidance and expertise regarding audit strategies and approaches.

Problem Solving

• Solves complex and diverse problems, takes a new perspective on existing solutions and exercises judgment based on the analysis of multiple sources of information using specialized knowledge of various alternatives and their impact on the business
• Works independently within broad guidelines and policies, receives minimal guidance

Building Quality Culture

• Supports and provides guidance towards training, technical tools and driving continuous improvement and efficiencies to support a preventive quality culture.
• Act as a thought leader in applying the intent of regulations, not just procedural compliance.

Communication

• Explains difficult or sensitive information to facilitate productive discussion; works to build consensus
• Regularly leads discussions and makes presentations in cross-functional meetings, effectively presenting information to explain recommendations and implications

Required qualifications:

• Bachelor’s degree in relevant field and
• 7+ years CAPA/NCEP or equivalent experience
• Proven leadership success through direct or indirect supervisory experience or experience leading cross-functional teams, implementing strategies, and achieving measurable results
• Understanding of regulations and standards applicable to the BSC Global Quality System and CAPA, NCEP and PIR processes (ISO 13485, 21 CFR 820, EU MDR, etc.)
• Experience with CAPA and CAPA concepts

Preferred qualifications:

• Master’s degree in Engineering, Quality, or related technical discipline
• Quality system experience in the medical device industry
• Strong working knowledge of FDA QSR, ISO 13485, ISO 14971, and post-market requirements.
• Strong verbal, written communication skills, both technical and conversational
• Experience supporting or leading audits and interacting with auditors as a CAPA/quality SME.
• Experience collaborating with international regions

Requisition ID: 623767 

Minimum Salary: $ 102100 

Maximum Salary: $ 194000 

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.