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Quality Systems Manager I

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

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:
The Quality Systems Manager I will be responsible for managing a staff of quality system professionals with primary responsibilities for the Internal Audit and CAPA processes at the Arden Hills site. This role will also partner with cross-functional teams and a global network to execute, standardize, and improve these processes. Additional activities will include providing guidance and mentoring across site functions regarding quality system compliance. 

This is a hybrid position based in Arden Hills, MN with the expectation to be on-site 3 days a week.

Your responsibilities will include:

  • Site ownership of systems including Internal Audit and CAPA.
  • Establish, support, and promote a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System requirements and appropriate regulations.  
  • Ensure employees are trained to do their work and their training is documented.
  • Lead a team of employees in the achievement of organizational goals; provide guidance and training to staff, assist them in attaining career goals, and recruit and maintain a high-performing team.
  • Foster a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • Manages Quality System activities/initiatives and communicates performance to senior leadership.  Lead quality meetings regarding quality and/or compliance improvement.
  • Develop and implement quality strategies; seek innovative approaches to attaining quality goals.
  • Drive quality projects of moderate scope.
  • Review and approve NCEP, CAPA and Internal Audit documentation.
  • Assist in development of department budget and monitor spending.
  • Determine appropriate staff levels and schedules; work with key partners to understand priorities and plan resource allocation accordingly.
  • Maintain and enhance cross-functional team relationships.
  • Monitor and ensure compliance with company policies and procedures.
  • Serves as a Quality representative to improve awareness, visibility and communication on quality initiatives to support department, functional, site, divisional and/or corporate quality goals and priorities.

Required qualifications:

  • Bachelor’s degree with 4+ years of related work experience within medical device quality or related discipline 
  • Experience with NCEP, CAPA and Internal Audit processes
  • Project management skills

Preferred qualifications:

  • Demonstrated leadership ability
  • Conflict management and negotiation skills
  • Excellent interpersonal skills
  • Excellent written and verbal communication
  • Subject Matter Expert level experience in BSC Quality Management System Processes and Sub-Processes and BSC systems

Requisition ID: 559912

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 drug-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.

Nearest Major Market: Minneapolis

Job Segment: Medical Device, Internal Audit, CAPA, Quality Manager, Project Manager, Healthcare, Finance, Management, Quality, Technology

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