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SUPPLIER QUALITY ENGINEERS - NEW
Reference: THQSE16084434
Job type: Permanent Full time
Salary: Not disclosed

SIGMAR RECRUITMENT - CORK

A LEADING MULTINATIONAL COMPANY BASED IN CORK REQUIRE AN EXPERIENCED SUPPLIER QUALITY ENGINEER DEGREE QUALIFIED WITH STRONG AUDITING EXPERIENCE IN A MANUFACTURING ENVIRONMENT.

 

 

Key Responsibilities:

  • Provides leadership for activities related to bulk packaging, sampling, distribution, sterilization, and product release to meet their area's objectives of quality, cost and output.
  • Demonstrates a thorough understanding of quality standards, including MDD, ISO13485, 21CFR 820, 21CFR 210/211.
  • Contributes to the development, maintenance and improvements of post production policies and procedures.
  • Provides guidance to other functional areas in applying product release and distribution quality system requirements.
  • Identifies and resolves exceptions to work practices. Works with product line engineering to assess and address material quality issues as a result of issues occurring post production.
  • Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
  • Contributes to and participates in Non-conforming Review Boards.
  • Acts as a leader of quality within the area constantly promoting awareness of best industry practices.
  • Assists in establishing and implementing Post Production Department improvement projects and goals.
  • Participation in and leadership of CAPA teams.
  • Subject matter expert for the area during external audits.
  • Approval of change requests for product, process and quality system changes.
  • Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities and as input to Management review.
  • Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects

    Skills, Experience & Qualifications:

  • Bachelor's Degree in Engineering, Science or Quality Assurance.
  • At minimum 4 years experience in an Engineering / Quality role in a pharmaceutical/medical device environment with direct experience in a GMP regulated environment a distinct advantage.

    •  

  • Strong Auditing experience is essential
  • Experience in FDA environment is desired 
  • Strong team member with the ability to identify and drive quality improvements.
  • Ability to work with minimum supervision.
  • Excellent interpersonal and communication skills.

    •  

    For further information, Please contact Timmy Hayes, Technical Recruitment Consultant @SIGMAR RECRUITMENT, (021) 4315770

    Or send CV in strictest confidence to thayes@sigmar.ie

    Your details will not be submitted for this or any role without your expressed permission .

     

    Do you know any suitable candidates for this role? Is so, you can win a €150 Voucher! All you have to do is refer Candidates to us and you get the voucher once the referred candidate is successfully placed in a job by Sigmar! Ask your friend to contact us. And remember, there is no limit to the amount of vouchers you can win. The more successful candidates you refer, the more vouchers you can earn!!

     
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