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Quality Compliance Manager, Cardiology

Quality Compliance Manager, Cardiology

Boston ScientificSaint Paul, MN, US
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Quality Compliance Manager, Cardiology

Work mode : Hybrid

Onsite Location(s) : Arden Hills, MN, US, 55112

Additional Location(s) : US-MN-Arden Hills

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 Compliance Manager is responsible for developing, implementing, and maintaining compliance documentation, conducting internal audits, and driving continuous improvement initiatives. This role works cross-functionally to ensure adherence to regulatory standards and Boston Scientific quality requirements, while also leading key compliance and training teams.

Your Responsibilities Will Include :

  • Ensuring adherence to regulatory standards and internal quality requirements
  • Collaborating with Compliance, Legal, and Quality teams to ensure a coordinated approach to quality and compliance
  • Developing and maintaining Standard Operating Procedures (SOPs) and policies related to quality assurance and compliance
  • Monitoring training operations and activities to ensure compliance with regulations and standards
  • Developing and administering compliance training programs for staff
  • Conducting and managing internal audits to verify compliance with relevant Boston Scientific standards
  • Investigating and resolving compliance issues and complaints, including corrective and preventive actions (CAPA)
  • Maintaining accurate documentation and generating reports related to compliance activities
  • Driving continuous quality improvement initiatives
  • Leading and managing the Quality / Compliance, Learning Management System, and Centers of Training teams

Required Qualifications :

  • Bachelor's degree or equivalent industry experience
  • Strong analytical skills and attention to detail
  • Excellent communication and interpersonal skills
  • Preferred Qualifications :

  • 12 years of quality experience, preferably in the medical device or combination product field
  • Experience working within an FDA-regulated environment
  • Proven ability to manage compliance programs
  • Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

    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!

    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.

    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.

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    Quality Manager • Saint Paul, MN, US

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