Quality Compliance Engineer

My client, a top 5 global EMS company with a base in Cork has been the EMS provider for end to end contract manufacturing and design services to some of the world’s most innovative companies for 25 years in their Cork site. The facility is FDA registered and certified to ISO 13485:2003 for the manufacture of high quality PCBAs, subassemblies and complete devices up to and including Class III Medical Devices with 90% of the site being in the Medical Device sector.

The Position:

This position is a 1 year fixed term contract with potential for longer term opportunity for the right candidate. The primary objective of the position is to join a brand new taskforce of 4 Quality Compliance Engineers reporting directly into the Quality Director to identify, define and implement key processes and system improvements so that they are closed off. This role is quite high profile and involves a lot of responsibility. As part of your role, you will be involved in:

  • Process mapping, procedural review and development, work instructions review and deployment site wide
  • Support QMS integration activity across the site
  • Ensure timelines of ECR’s/SCN’s/CAR’s/PAR’s/SCAR’s and customer SCAR’s
  • Improve site compliance and adherence to GMP/GxP

The Person:

  • Level 8 technical degree
  • At least 6 years experience in a medical device or highly regulated industry
  • At least 6 years technical Functional/Manufacturing experience i.e QA, Validation, standards and systems
  • Incredibly high attention to detail
  • High level of GMP Audit experience
  • Good knowledge of process tolerances
  • Great communicator, as well as identifying the changes that need to be made you must be able convince others to implement them
  • Have the ability and track record of working in a very fast paced environment

The Benefits:

Salary between €80,000 and €90,000 based on experience along with full healthcare and pension available after 6 months.

For more information on this role, apply now or call Chris Dennehy at HRM on 021 4511195

Salary: €80000 - €90000 Location: Cork