QA Engineer

at  Matrix Recruitment Group

JOB DETAILS

Posted 03 April 2024
LocationCounty Leitrim
Job type Permanent
Discipline Engineering, Manufacturing
Reference10765-M
Contact NameAshley Egan

WHAT YOU NEED TO KNOW

Our client, an Irish-based medical device company who are currently seeking an experienced QA Engineer to join their organisation.
This is a full-time position where you will be required to be on site in Co Leitrim.
The QA Engineer will be reporting into the Senior QA Engineer and will work within part of a team.

WHAT YOU NEED TO KNOW?

• Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum Bachelor’s degree in a Science / Engineering / Quality related discipline.
• 2-3 years’ experience as Quality/Validation Engineer in Medical Device/Pharmaceutical Environment
• An Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.
• A Senior position may exist for a minimum of 6 years’ experience
• Fully PC literate, use/knowledge of Minitab would be beneficial
  Apply for this job now by sending in a Word version of your CV or get in touch with Ashley at ashley@matrixrecruitment.ieor alternatively by phone at 087 113 7061.

KEY DUTIES & RESPONSIBILITIES:

• Integration & Maintenance of the Quality Management System with all the clients’ processes in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
• Deputizing for the Management Representative in their absence.
• Provision of support to all departments to ensure that products manufactured meet customer requirements.
• Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
• Review and Release of batch paperwork for Product release.
• Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13485. Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
• Maintenance of the Customer Complaint investigation process, MDD 93/42/EEC & MDR 2017/745 vigilance requirements assisting in product recalls & corrective/ preventive action programme.
• Participation in routine Failure Investigation & process troubleshooting.
• Maintenance of plant Trending & Continuous process improvement programmes.
• Participation in the Plant Corrective Action Programme.
• Participation in the Internal Quality Audit Programme.
• Co-ordination & maintenance of the Calibration Programme & Validation Programme.
• Maintenance of the Plant Environmental & Cleaning/ Housekeeping Programme, including sub-contractor maintenance.
• Maintenance of the Plant Laundry & Rodent Control Sub-Contractors to required standards.
• Ensuring that quality system & product requirements are included in the plant Training Programmes designated trainer.