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Senior Quality Engineer, Quality Divisional Support

Job Title: Senior Quality Engineer, Quality Divisional Support
Contract Type: Permanent
Location: Galway
Industry:
REF: 90900
Job Published: 8 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 0868395533

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.


Our Offer
  • 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.
Qualifications
  • 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.
For further information on this Senior Quality Engineer, Quality Divisional Support role in Galway please contact Bimi Felix on 0868395533 / bimi@hero.ie
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