Senior Reliability Engineer
Our client, a medical device company in Cork are currently looking to recruit a Senior Reliability Engineer for their site on a contract basis.
- 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.
- 3+ 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
- Experience in conducting failure investigations, reliability testing, and/or performing failure analysis leading to Root Cause and Corrective Action
- Demonstrated applied knowledge of Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, and Mistake Proofing/Poka Yoke.
- Demonstrated ability to read and interpret CAD drawings
- Demonstrated ability to advocate product excellence and quality
- Demonstrated ability to effectively work cross functionally with other departments including Advanced Operations, Product Development, Regulatory and Marketing.
- Demonstrated problem-solving and troubleshooting skills.
- Demonstrated interpersonal and communication skills.
- Demonstrated a positive, energetic approach to teamwork.
- Demonstrated ability to learn quickly and multi-task
- Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
- Computer proficiency with Mini-tab or similar analysis program, Visio, MS Office
For further information on this Senior Reliability Engineer role in Cork please contact Bimi Felix on 091730022 / email@example.com
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