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Senior Quality Specialist Job

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Date: Oct 1, 2021

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

Additional Locations: This role can be based in any Boston Scientific major facilities in the US or Costa Rica. (US-MN-Arden Hills; Costa Rica-Coyol; Costa Rica-Heredia; US-CA-San Jose; US-CA-Valencia; US-IN-Spencer; US-MA-Marlborough; US-MN-Maple Grove)

 

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 Quality Specialist

 

About the role:
Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities.  Collaborates with Quality management to recommend, design and implement functional process improvements.  Develops, establishes and maintains quality methodologies, systems and practices which meet BSC, customer and regulatory requirements.  Provides compliance guidance and support for technical development concepts, regulatory, operational, or systems/services.  May mentor cross-functional stakeholders on implementing Quality processes and procedures as appropriate.

 

Key responsibilities include:

  • Lead data management activities within the BSC UDI (Unique Device Identification) system
  • Support development and maintenance of quality system procedures related to UDI requirements
  • Support development and maintenance of IT/database systems
  • Assess new UDI related global regulations and requirements for impact and implementation
  • Provide guidance on UDI interpretation questions to ensure consistent compliance to regulations and internal procedures
  • Support compliance analysis and metrics
  • Develop and deliver communication and training 
  • Participates on NCEP/CAPA teams as appropriate
  • Other duties as necessary or required by the department or organization.

 

What we're looking for in you:
Minimal requirements:

  • Bachelor's degree and 5 years of related work experience
  • Familiarity with interpreting requirements and/or regulations
  • Ability to analyze data against requirements
  • Excellent written and oral communication, technical writing and editing skills
  • Strong sense of responsibility and attention to detail
  • Ability to actively engage divisional and regional resources
  • Ability to work with a virtual team
  • Ability to work in a fast paced, self-directed, environment
  • Advanced Microsoft Office Suite skills 

Preferred qualifications:

  • Understanding of Unique Device Identification (UDI) requirements for medical devices 
  • Understanding of the BSC UDI system and procedures
  • Experience as a system product owner
  • Experience with AGILE methodology
  • Understanding of data management / information management
     

 

 

Requisition ID: 503045

 

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.

 


Nearest Major Market: Minneapolis

Job Segment: Medical, CAPA, Law, Quality Manager, Quality, Healthcare, Management, Legal