Quality Engineer

 

Description:

I am working with a large medical device organisation based in Waterford who are currently expanding their Quality function and will be looking to hire several Quality Engineers over the coming months.

 

About the role:

  • Reports to Quality Function
  • Monday to Friday office hours
  • Dealing with Customers, Contractors, Vendors and Suppliers
  • On site full time in Waterford
  • Full Time Permanent position

 

Key Responsibilities and End Results:

  • Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
  • Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA’s & support the generation of DMF’s where appropriate.
  • Uses scrap reduction methodologies and process capability analysis to provide a robust defect free process.
  • Individual with an experienced background in sterilisation, automation, equipment/software validation.
  • Individual with an experienced background in manufacturing within controlled environments.
  • Individual shall support the external & internally Quality Management System auditing function (auditor trained).
  • Individual shall have exposure & involvement in supporting the CAPA system.
  • Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
  • Support the implementation of Company Policies and GMP.
  • Support all company safety and quality programs and initiatives.
  • Ensure ongoing compliance with GMP in all practices, recording of events and processes.
  • Ensure compliance with all learnings from all GMP training events.
  • Root cause problem solving approach in a team environment.
  • Aligning customer specification to company capabilities.
  • Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

 

The minimum education and experience requirements:

  • Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline.
  • 1-5 years’ experience in a Quality Engineering role.
  • Fully competent in Quality Management Standards.
  • Currently be based in Ireland and willing to be onsite full time.
  • Hold a valid visa currently.

Organization ACCPRO
Industry Engineering
Occupational Category Quality Engineer
Job Location Dublin,Ireland
Shift Type Morning
Job Type Full Time
Gender No Preference
Career Level Intermediate
Experience 1 Year
Posted at 2024-08-30 12:16 pm
Expires on 2024-12-23