Quality Projects Engineer



Quality Control

Product Manager

Date Posted:

June 12, 2019, 8:28 a.m.

Work schedule

Continuing full split


Full time




Not specified/Negotiable


More than 6 years



Job Overview:


  • The Quality Engineer is a Project based role & he /she will be responsible for Quality within their prescribed project.
  • S/he will primarily be responsible for transfer of production documentation and developing / executing Validation documentation.
  • S/he will be working as part of a team to maintain high quality / performance standards on all Creganna Medical products.
  • This role includes customer interfacing both internally and externally, which requires a high level of professionalism and responsibility.
  • This challenging position will require an ability to work with minimum supervision and ensure compliance to the Creganna Medical Quality System.





  • Support Project Manager / Mentor Team Leaders / production teams to achieve business objectives & performance in line with Project goals and KPI’s
  • Overall responsibility for production GMP standards and compliance.
  • Establishing inspection standards, plans, frequencies and test methods.
  • Establish a production process documentation at the receiving site which aligns with sending site controlled process through transfer of all relevant documentation
  • Preparing and updating Operations procedures and associated documentation while maintaining compliance with quality standards and customer requirements
  • Perform an active role in project planning and risk management from a quality perspective.
  • Have a good working knowledge of ISO/FDA/MDD and other Manufacturing related regulatory requirements.
  • Maintain relevant documentation to comply with quality standards and customer requirements.
  • Development and executing Validation documentation which aligns with the receiving sites Quality system.
  • Develop strong links with customer organisation’s and other project stakeholders.
  • Supporting customer and surveillance accreditation audits.
  • Performing an active role in further development and continuous improvement of the quality management system.
  • Other duties as assigned from time to time.





  • Degree in Quality or Degree in Science / Engineering.
  • Experience within a similar role as quality engineer.
  • 5+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.
  • Working knowledge of FDA and ISO Quality systems for Medical device companies.
  • New product introduction and manufacturing process transfer experience would be a distinct advantage.
  • Experience in developing and executing Equipment and Process Validations
  • Quality experience in component and device manufacturing desirable.
  • Excellent written and oral communication skills essential.





Values: Integrity, Accountability,Teamwork, Innovation




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