Senior Quality Engineer, Quality Divisional Support
Our client, a medical device company in Galway are currently looking to recruit a Senior Quality Engineer, Quality Divisional Support for their site.
- You will understand therapy (clinical) performance, disease states, product functions(s), and product use conditions to appropriately and strategically apply supplier selection, development, component qualification and production control plans.
- You will be responsible for defining supplier objectives and design requirements, partner with suppliers to ensure components are designed for reliability, manufacturability, and cost reduction via component specifications.
- Ensure supplier feedback is included in the development process.
- You will analyze supplier qualification results, report performance, and demonstrate release readiness.
- Author or review key component engineering lifecycle deliverables throughout product development, as defined by procedures.
- Define control plans to ensure appropriate acceptance activities.
- You will drive supplier requirements and supplier performance objectives by collaborating effectively with Design, Development Engineering, Technical Sourcing, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs.
- You will be leading NCMR activities related to components, ensure corrective and preventive measures meet acceptable standards of robustness and effectiveness.
- Resolve components/material failures and focus actions on the root cause.
- Assure compliance to procedures and timely completion of CAPAs and audit findings.
- Your responsibilities may include Project Management of small projects, Research & Technology (pre-IDE) projects, leading cross-functional improvement initiative teams, leading Design for Reliability and Manufacturability thinking and work practices to demonstrate functional excellence.
- We are looking for a qualified person with 4 years of experience in related engineering discipline with Bachelor's degree level 8 or 3 years with Master's in engineering, science or related field.
- You are a dynamic team player and can work effectively and proactively on cross-functional teams.
- You are experienced with medical device industry or highly regulated industry.
- You are a good communicator and fluent in English, both in writing and speaking.
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