- Reference: LK46008
- Job Type: Permanent
- Location: Clare, Limerick, Tipperary
- Category: Engineering, Technical & Manufacturing
Title: QA Specialist
Collins McNicholas is seeking a “QA Specialist -Operations” for our Multinational Client based in Limerick. Your chance to change lives awaits….
Our client designs and manufactures medical devices which help improve peoples lives. If you can develop, coach and mentor others while working in a cross functional team demonstrating excellent interpersonal skills you should read on.
The Responsibilities include but are not limited to:
- Quality representative in contract/order reviews, ensuring the company and Customer specification and drawings are aligned.
- Designee to the Area QE for the direction and resourcing of QA product testing and release activities, including disposition of non-conforming material.
- Actively involved in generating temporary deviations, WI’s and rework instructions to assist with process improvement trials, sorting, re-inspecting and re-working non-conforming product.
- Trouble shooting quality issues within the manufacturing processes and driving solutions to reduce non-conformances.
- Provide support for Internal, Supplier, Customer and regulatory audits.
- Key driver in Customer complaints handing, risk assessment, failure investigations and CAPA implementation and verification.
- Third level degree in Engineering/ Quality Assurance/Science discipline
- 2-5 years relevant experience in a regulated environment
- Planning, Organisation and Project Management skills
- Experience of Structured Problem Solving techniques
- Understanding of Lean Principles
- Ability to drive for results
- Technical report writing skills
- Understanding application of Statistical analysis
- Knowledge of respective standards and good manufacturing practices.
- Willing and able to work on own initiative
- Knowledge of requirements and practices for FDA /ISO 13485 environment
To apply for this role please forward your CV to email@example.com or for a confidential discussion please call 061 512270.