|Role Type||Fixed Term Contract|
Associate Quality Engineer
Job ID: JOB-11688
Title: Associate Quality Engineer
Duration: 12 months FTC
Location: Parkmore/ Working from home until allowed back on site
Start Date: ASAP
My client, a leading medical device company in Galway is looking to hire an Associate Quality Engineer on a contract basis.
The Associate Quality Engineer provides a support role to the Quality Manager in the routine maintenance of the Quality and other business Management Systems.
Reporting to: Quality Manager
Key Responsibilities: (Not limited to the below)
- Cross alignment between the Customer Service functions (both International and Domestic) and the Quality function.
- Understands the Quality Management System (QMS) in place, Company Standard Operating Procedures (SOP’s) and Work Instructions (WI’s) and works in compliance with established procedures and/or protocols.
- Works with all CS staff and related departments to investigate QI’s and then prepares and manages all functional QI documentation in Agile in an accurate and timely manner, adhering to timelines for completion at each stage.
- Works with all CS staff and related departments to prepare and manage all functional CAPA’s documentation in Agile in an accurate and timely manner, adhering to timelines for completion at each stage.
- Drives alignment across related departments to receive accurate and timely input into all QI and CAPA actions.
- Management and support for any Field Safety notices that need to be issued to customers.
- Periodic Functional review of SOP’s, WI and Documentation and alignment with the Quality department to ensure these are done in alignment with policies, timelines and protocol.
- Represents Customer Service in all Continuous improvement meetings – Administration and support of the CAPA/ NC process through weekly continuous improvement meetings with Quality.
- Works in compliance with established procedures and/or protocols. Identifies and resolves readily identifiable, clearly-defined problems. Demonstrates skill in data analysis techniques by resolving missing/incomplete information in routine assignments.
- Possesses and applies a fundamental and increasing knowledge of Quality, and its application within Abbott to the completion of routine assignments.
Key Skills & Experience:
- Minimum 1 years’ experience in medical device industry.
- Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP).
- Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL).
- Experience in writing up Quality Incidents and CAPA’s in a concise and compliant format.
- Competency in conducting technical review of all documentation / communications.
- Broad knowledge of engineering and technical applications applied in development of medical devices useful.
- Previous experience with international order management or Subject matter expert on International Customer Service processes, procedures and exceptions is desirable.
For further information on this role please contact Shane Connolly on 0872197421 or email@example.com
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
Job ID: JOB-11736 Senior Quality Engineer – Process Validation A leading medical device manufacturer in Galway is recruiting for a…
Job ID: JOB-11735 Senior Operations Manager Our client a medical device MNC is recruiting for a leadership role in Galway….
Job ID: JOB-11731 Planner/Buyer Our client in South County Galway is recruiting for a planner/buyer to join their team, you…