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Quality Systems Engineer II -Clonmel Job

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Date: Feb 5, 2019

Location: Clonmel, TA, IE, 0

Company: Boston Scientific

Additional Locations: (n/a)

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

      Purpose:

 

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.  Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.

 

           Responsibilities:

 

  • Demonstrate a primary commitment to patient safety and product quality.
  • Responsible for the implementation, co-ordination and continuous review of the CAPA, Internal and Corporate Compliance programs in Boston Scientific Ireland Ltd.
  • Has expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO and MDD/MDR ).
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Drives changes in procedures and standards to facilitate work efficiency and to maintain quality.
  • Familiar with the internal auditing system.
  • Acts as a leader of quality, QSR and ISO/MDD/MDR standards within one’s own group, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.

     

    Requirements:

     

    In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

     

      Qualification & Experience:

     Level 8 qualification and 2 to 4 years relevant work experience

 

 

 

 

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Requisition ID: 440791

 


Job Segment: Quality Engineer, Medical, Engineer, CAPA, Engineering, Quality, Healthcare, Management