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Quality Director Job

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Date: Nov 8, 2021

Location: Maple Grove, MN, United States, 55311

Company: Boston Scientific

Additional Locations:

 

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 Director of Quality Assurance leads a team of QA Managers, Senior Engineers, Engineers, Technicians and other QA professionals to ensure full compliance to all GMP/QSR practices and standards as defined by the Food and Drug Administration, ISO and other regulatory bodies.

 

Your responsibilities will include:

  • The QA Director will provide leadership and direction to their team and ensure a Quality Management System exists to meet the various requirements of a medical device manufacturing facility.  Specifically, they will ensure that the necessary monitoring of environmental controls, management of documentation process’s including storage, retention and review, establishment of internal auditing programs, verification of all products and process’s to the established quality standards through 100% testing or statistically valid sampling.  Validation of new products/process’s or changes to existing products/process’s, establishment of a vendor review and rating systems are in place on Site.
  • The QA Director will build a strong and sustaining relationship with Production, Engineering, Corporate QA/Regulatory, external Regulatory bodies and others and will be recognized as and excellent team player within the total organization on site.
  • They will be committed to developing people and is recognized as an expert in mentoring and coaching individual and team performance while visibly demonstrating the core values of BSC in their everyday leadership style.
  • They will continuously foster and drive a continuous improvement approach to Quality on Site ensuring that quality is the responsibility of everyone - not just the QA department and that the Quality System is an integrated and integral aspect of the total running of the Site.
  • May serve as Quality System Management PRRC (Person Responsible for Regulatory Compliance) Representative (Article 15 of the Medical Device Regulation 2017/745), ensuring that conformity of devices are appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. (Article 15a).  Ensures that post-market surveillance obligations are complied with Article 10(10). (Article 15c) and that vigilance reporting obligations referred to in Articles 87 to 91 are fulfilled (Article 15d).  Remains at the disposal of the EU Authorized Representative and shall suffer no disadvantage within the manufacturer's organization in relation to the proper fulfilment of his/her duties.
  • May lead a group or team of employees in the achievement of organizational goals.  Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).


Required Qualifications:

  • Minimum of a Bachelors Degree
  • Minimum of 10 years of related functional and leadership experience within the Quality space. 
  • Minimum of 5 years of direct managerial experience leading large and diverse teams across a highly matrixed organization
  • Medical device or related industry experience
  • 5% travel required


 

Preferred Qualifications:

  • Masters degree preferred
  • Senior executive presence, comfortable presenting and collaborating with Senior Leaders as a Business Advisor
  • Ability to successfully manage and execute multiple, large scale projects using established project management tools and processes.
  • Demonstrated capability in collaborating and partnering within a complex and matrix global distribution and manufacturing environment
  • Demonstrated high degree of integrity, professionalism, and ability to establish credibility
  • High sense of urgency and commitment to execution


 


 


 

 

 

 

Requisition ID: 511660

 

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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