- Reference: LK45363-4
- Job Type: Permanent
- Location: Clare, Limerick, Tipperary
- Category: Production
Title: Quality Engineer
Location: Mid West
My client an American Multinational with Operations in Limerick is looking to hire a Quality Engineer to oversee quality input, review and release during new product development including supplier and part approval through to transfer to manufacturing processes.
- Quality lead on vendor and part appraisal and approval processes.
- Monitor and drive compliance within the development process and/or operations to GMP and the requirements of the QMS within assigned area.
- Ensure that appropriate quality plans, test methods, test plans , validation and risk (FMEA) documentation, are all in place and being adhered to during product development.
- Key driver in Customer complaints handing, failure investigations and CAPA implementation and verification.
- Establish and monitor process quality performance to determine when improvement actions are appropriate.
- Ensure full compliance with regulatory requirements.
- Oversee product testing and release activities, including disposition of non-conforming material, the identification of scope, control of related NC material, root cause and appropriate CAPA actions and thorough documentation of same within schedule.
- Degree in an engineering/ quality related discipline
- Certified QE
- Technical report writing
- Process validations/FMEA’s and protocols
- Statistical analysis
- Structured Problem Solving techniques
- Understanding of Lean Principles
- Ability to drive projects to completion
- Guided by the disciplines of due diligence and compliance in all aspects of work.
- Working knowledge of EN ISO 13485 the MDD 93/42 EEC and principles of GMP and FDA QSR 21 CFR Part 820 required
To apply for this role please forward your CV to firstname.lastname@example.org or for a confidential discussion please call Ben on 061 512 274.