Sr Quality Manager

1 month ago


Clonmel, Ireland Boston Scientific Full time

Additional Locations:  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.

Dynamic Senior Quality Management role to lead all aspects of product transfer of BSC Cholangioscope and Duodenoscope products from the BSC Spencer facility to BSC Clonmel, including the set-up of manufacturing lines and associated processes at our Clonmel facility in adherence to BSC Quality System and External Regulatory requirements.

The Senior Manager will partner with other functional Senior Managers, divisional partners and the global BSC network to meet customer and business needs in addition to driving efficiencies and improvements of the Quality System and Products.

This role is also responsible for establishing an environment of continuous improvement and prevention in addition to cost reduction to ensure we are always improving the quality of products, processes and business needs.

Ensure that systems, processes, and staffing are suitably designed and implemented to meet all transfer and production unit set-up timelines while maintain full compliance to the BSC quality system and regulatory requirements.

 

 Responsibilities:

  • Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
  • Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, DEKRA and all other geographical medical devices regulations.).
  • Makes effective decisions regarding work processes or operational plans and schedules in order to achieve functional and team objectives.
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
  • Establishes and promotes a work environment that supports the BSC Quality Policy and Quality System.
  • Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product.
  • Ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities as required.
  • Minimize the number of product field events through effective and timely investigation activities in addition to management of associated corrective actions.
  • Work cohesively and seamlessly with Production and Engineering counterparts for the delivery of both strategic and financial objectives.
  • Direct and control the activities and budget of functional areas, divisions, product groups, projects/programs and/or operations.
  • Recruits, coaches, and develops organizational talent.
  • Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational and personnel objectives.
  • Provides direction and guidance to quality professionals and/or other functional employees on matters related to quality.
  • Keeps the organization's vision and values at the forefront of decision making and action.
  • Demonstrates effective change leadership.
  • Deliver on BSI and DEKRA extension to scope/maintenance audits and oversee production unit audit readiness at all times.

 

 
Qualifications:
Bachelors’ honors degree required in Engineering or Science Discipline.
 
Experience:

  • Minimum of 5 years quality leadership experience in a medical device or similar regulated industry
  • Minimum of 3 years people leadership at management level.

 

Requisition ID: 579907

 

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



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