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Quality Validation Engineer

Job Seekers Ireland Engineering, Science Manufacturing

Job Summary

  • Waterford
  • Permanent
  • BBBH809567
  • Apr 05, 2022
  • Competitive
Job Description

I am currently seeking a Quality Validation Engineer to join an exciting Medical Device company who are continually growing based in Waterford.

This person will generate and execute validation documentation for the moulding, assembly, test equipment, facilities, and supplier validation within the Quality Management system. This is a full-time permanent role and will be based predominantly on site.

You will have a degree in science or engineering with 2-3 years industry experience in a quality validation role with strong process validation. Excellent working knowledge of QE tools and techniques required with particular knowledge of ISO 13485, GAMP5 and FDA regulations. Experience in method validation and process characterization also advantageous. You must work well as part of a core team and have strong communication and organisational skills.

Responsibilities:

  • Write validation protocols and amendments of the quality management system in line with regulatory agency directives and requirements including the FDA and the HPRA within the medical device and pharma sector.
  • Cross collaborate with other divisions within to drive quality initiatives.
  • Develop and manage validation projects.
  • Work closely with automation and moulding vendors.
  • Support company safety, ongoing compliance within GMP practice and training events.
  • Generate risk assessment documents for regulated processes within quality.
  • Problem solution using LEAN 6 sigma where applicable.
  • Train and mentor as needed.

For more information on this role 'apply now' or contact me on aodriscoll@morganmckinley.com

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Aoife O'Driscoll
Aoife O'Driscoll
  • Senior Consultant | Engineering Recruitment
  • +353 (0) 21 2300300
  • aodriscoll@morganmckinley.com