Senior Reliability Engineer
Our client, a medical device company in Limerick are currently looking to recruit a Senior Reliability Engineer for their site on a contract basis.
Job Description / Information
- 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.
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