Senior Quality Manager - Installation & Servicing (I&S) Quality System Steward
Arden Hills, MN, US, 55112
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 a Senior Quality Manager – Installation & Servicing (I&S) Quality System Steward to lead the global governance, compliance, and continuous improvement of our Quality System processes related to installation and servicing of our capital equipment products.
In this high-impact role, you will serve as the Quality process owner and subject matter expert for I&S within the Boston Scientific Quality System. You will ensure these processes remain compliant with evolving global regulations, connected to other quality system elements, and supported by well-designed processes, digital tools and systems.
You’ll lead a team of Business Process Engineers dedicated to designing and maintaining effective, compliant, and efficient processes that support our global service and commercial teams. You will partner closely with Service teams globally to ensure Boston Scientific’s global I&S framework continues to enable safe, effective, and customer-focused service operations.
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.
Your responsibilities will include:
- Serve as the Global Process Steward for Installation & Servicing within the Quality System—owning the design, documentation, and continuous improvement of associated procedures, standards, and tools.
- Ensure I&S processes comply with global regulatory requirements (FDA QSR, ISO 13485, ISO 14971, EU MDR) and remain integrated with other key Quality System processes.
- Collaborate globally with Commercial, Service, and Quality leaders to understand regional models, customer needs, and operational challenges, ensuring processes and systems evolve to support diverse market needs.
- Partner with IT and Digital Quality teams to ensure supporting systems (ERP, PLM, and Field Service platforms) are compliant, validated, and optimized for efficiency and data integrity.
- Lead global initiatives to standardize, simplify, and digitize service-related quality processes that enhance compliance and business performance.
- Act as the Subject Matter Expert (SME) for I&S in internal, corporate, and external regulatory audits.
- Develop and monitor key performance indicators (KPIs) to measure process compliance, effectiveness, and efficiency; lead management reviews and implement continuous improvement actions.
- Manage and mentor a global team of Business Process Engineers, fostering technical and leadership growth.
- Engage externally in industry and standards forums to represent Boston Scientific, influence evolving regulations and guidance, and bring industry best practices into our Quality System.
- Build strong, collaborative relationships across Boston Scientific’s global Quality, Service, Commercial, Regulatory, and R&D teams to ensure alignment and process excellence.
Required Qualifications
- Bachelors degree in Engineering, Science or related technical discipline
- Minimum of 8 years of experience in Quality Systems, Compliance, or Process Management within a regulated industry (medical device preferred).
- Minimum of 3 years of people leader experience
- Demonstrated success serving as a regulatory or process SME during audits and inspections.
- Knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971, and EU MDR.
Preferred Qualifications
- Masters degree in Engineering, Science or related technical discipline
- Proven success leading global quality or process management teams and influencing across functions.
- Deep understanding of installation and servicing requirements for medical devices.
- Experience working across multiple commercial regions with diverse business models and service operations.
- Experience with enterprise systems such as SAP, PLM, and Field Service Management platforms.
- Proven ability to influence externally through participation in industry forums, standards development, and professional networks.
- Exceptional leadership, collaboration, and change management capabilities.
- Strong analytical ability to monitor and improve process performance through data-driven insights.
Requisition ID: 618063
The anticipated annualized base amount or range for this full time position will be $ to $, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.
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 is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
Nearest Major Market: Minneapolis
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