Our client, a global leader within the Medical Device industry, are looking to recruit a Quality Engineer to add to their team in Cork on permanent basis.
- Responsible for ensuring all quality related activities associated with new product and process development is completed prior to transfer to manufacturing.
- Responsible for ensuring that the manufacturing process is fully validated and that the process capability is of the required sigma level prior to transfer to production.
- Work with product development to identify design risks and the implementation of necessary risk control measures prior to design transfer.
- Coordinate and lead all risk management activities in accordance with divisional procedures and corporate guidance.
- Actively participate on new product development teams to support product and process Design for Manufacturing (DFM) activities, including transfer to appropriate business unit(s).
- Participate in development, review and approval of process and equipment validation/qualifications (IQ, OQ & PQ).
- Participate in development of quality and inspection strategies/methods (gauging, etc.) to ensure a high level of Quality and Regulatory Compliance is maintained.
- Support process capability studies and ensure required sigma levels are achieved prior to transfer to production.
- Support research and identification of new technology solutions for manufacturing processes related to new product introductions.
- Drive implementation of key business operating systems and methodologies for new products.
- Ensure Attribute Test Method Validations (ATMV) are completed
- Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
- Approval of change requests for product, process and design aspects of the product.
- Support the implementation of Lean Manufacturing
- Build quality into all aspects of their work by maintaining compliance to all quality requirements
- Bachelor?s Degree in Engineering or a related discipline
- 2+ years? experience within a similar role
- Working knowledge of FDA and international medical device regulations is strongly preferred
- Proven strong experience and working knowledge in the application of Advanced Quality tools such as Design for Manufacturing, Failure Modes Effect Analysis (FMEA), Fault Tree analysis, GD&T, SPC, Root Cause Analysis, Mistake Proofing/Poke-Yoke, Problem Solving, and Process Mapping.
For further information on this Quality Engineer role in Cork please contact Cliona O'Malley on 091730022 / email@example.com
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