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Senior Manager Quality - Digital Health & Solutions Job

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Date: Sep 12, 2021

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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.

 

Senior Manager Quality - Digital Health & Solutions
 

About the Role:
Boston Scientific’s Digital Solutions team is dedicated to transforming the lives of patients and improving physician and provider experience globally. The team will deliver digital health solutions designed to improve health care delivery, optimize user experience, and reduce cost burden. We are currently looking for a strategic, passionate leader who will provide quality guidance and direction to the development and maintenance of digital services and applications. This role will lead a team of Quality Engineers  that engage with Digital Health Teams made up of multiple supporting functions in areas such as design requirements, verification and validation, risk management, usability, change control, problem resolution, CAPA, real world performance & post market surveillance, privacy and cybersecurity assessments for medical and health software applications.  This newly structured role will collaborate across the Interventional Cardiology (IC) division to execute on the IC Digital Strategy.
 

Your responsibilities include:

  • Provides leadership to ensure Digital quality methodologies, systems, and practices which meet BSC, customer, and regulatory requirements are met.
  • Applies in depth knowledge of the quality system and familiarity with various software development methodologies to influence process development and improvement strategies that balance quality requirements with agile development methodology. 
  • Lead all aspects of software quality in a globally regulated environment, to ensure development and sustaining activities are carried out in compliance with global policies and departmental procedures.
  • Plays a key role in vendor management by identifying the quality system needs from a vendor and ensures that vendors are qualified in a manner that enables smooth integration with the BSC quality system.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.
  • Plays a key role in partnering with Global Digital Quality team to navigate the Digital quality methodologies needs for the divisional Digital Strategy.
  • Lead a team in the achievement of organizational and divisional goals. 
  • Guide, coach, and direct team members, and drive best practices throughout the organization.
  • Evaluate and manage safety, security, and privacy risks for medical and health software applications according to the associated regulations and internal requirements. 
  • Provides Quality leadership in Digital Community meetings with partners in marketing, regulatory, legal, supplier management and Digital product development to drive actions to completion. 
  • Acts as an effective leader or team member in supporting Digital quality disciplines, decisions, and practices.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
  • Foster a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

 

What we are looking for in you
Minimal qualifications: 

  • Bachelor’s level degree in Science/Engineering/Software discipline 
  • 7+ years of related experience, including 5+ years’ experience supporting Quality Assurance for Digital or related discipline
  • 5+ years of direct supervisory experience with a passion for leadership and team development.
  • Medical Device or regulated industry experience.
  • Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11 and cGxP for Medical Devices
  • Must have good understanding of quality system requirements and how each quality system element connects
  • Experience in working with ‘Agile’ software development methodologies
  • Experience supporting projects that have followed the requirements as laid out in IEC 62304 for Device Software and/or as laid out in IEC 82304 for Health Software 
  • Experience working with a diverse population of internal and external customers 
  • Comfortable speaking and presenting to leadership 
  • Strong written and verbal communication skills 
  • Creative and innovative thinking skills 
  • Experience managing projects and project deliverables to completion 
  • Ability to manage multiple priorities and work with ambiguity 

 

Preferred qualifications:

  • Clinical background or knowledge of clinical evaluations and User Centred Design beneficial
  • Experience/Understanding of risk management as per ISO 14971 
  • Experience with CAPA, Vendor Controls, Complaint Handling and External Audits 
  • Basic Understanding of HIPAA/GDPR and data security regulations beneficial
  • Some Experience/knowledge of Cybersecurity and related Security Risk Analysis 
  • Some Experience/knowledge of digital platforms and development tools (such as Salesforce, GitLab, Bitbucket, JIRA, Pivotal Tracker, InDesign, etc.) 
     

 

 

Requisition ID: 483526

 

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.

 


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