Our client, a global leader within the Medical Device industry, are looking to recruit a Quality Complaints Engineer on a permanent basis for their site in Cork.
- Conduct/perform documented failure investigations on customer complaints leading to the identification of root cause and corrective/preventive actions.
- Ensure timely closure of complaints to comply with FDA requirements.
- Perform trend analysis and identify negative trends to target for improvement.
- Facilitate field actions as required.
- Provide support to new product development and risk management process, including FMEA and reliability testing.
- Bachelor?s Degree in Engineering or related field of study.
- Prefer CQE certification and Six Sigma Green or Black Belt.
- 5+ years of experience as a Reliability or Quality Engineer in a regulated design environment.
- Prefer experience with medical device product development life cycle, including risk management and design/ process verification & validation Knowledge of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971
For further information on this Quality Complaints Engineer role please contact Nicola O?Connell on 091730022 / firstname.lastname@example.org
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