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Senior Supplier Quality Engineer

Job Title: Senior Supplier Quality Engineer
Contract Type: Permanent
Location: Galway
Industry:
REF: 89743
Job Published: 11 months ago

Job Description

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

Senior Supplier Quality Engineer
Our client, a medical device company in Galway are currently looking to recruit a Senior Supplier Quality Engineer for their site.


Overview:
  • The Senior Supplier Quality Engineer is a member of the Operations Quality group.
  • S/he is responsible for Supplier Quality within their prescribed area of functional responsibility.
  • The successful candidate will lead and work as part of a team to maintain high quality / performance standards on all company products.
  • Reporting to the Operations Quality Manager, the position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision.
Responsibilities & Qualifications:
Major Accountabilities:
  • Supervision and direction of Supplier Quality personnel (Engineer and Technician grade).
  • Lead and drive Supplier QA initiatives within area of functional responsibility.
  • Provide supplier quality input and support to the manufacturing, engineering, prototype and commercial functions.
  • Investigating root cause of supplier issues (SCAR) and ensuring follow-through of timely and effective corrective actions to prevent re-occurrence.
  • Strategically lead new material introduction and support new product launches to ensure supplier quality meets the required standards.
  • Lead and support (as an auditor) various audits of a diverse supplier base.
  • Perform on site supplier visits for root cause analysis and verification of corrective actions of supplier quality issues.
  • Reporting functional Supplier Quality metrics.
  • Preparation of Supplier Quality reports for various meetings and management forums.
  • Review supplier manufacturing processes, collaborate with suppliers on process improvement and value enhancement opportunities.
  • Facilitate the escalation of unresolved supplier quality issues.
  • Ownership of the Material Review Board process within the Galway site.
  • Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements
  • Develop strong links with customer organizations and other project stakeholders.
  • Supporting internal and external audits to ISO and FDA requirements.
  • Performing an active role in further development and continuous improvement of the quality management system.
  • Other tasks as directed by the Operations Quality Manager in line with company goals and objectives.
Education:
  • Degree in Science / Engineering or related fields essential.
Requirements:
  • Minimum of 5yrs industry experience in a medical device-manufacturing environment.
  • Clear understanding medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.
  • Strong CAPA experience.
  • Strong root cause analytical and problem solving skills.
  • Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable.
  • Auditor certification and experience desired.
  • Demonstrated excellent organizational skills and ability to work on own initiative essential.
  • Supervisory experience desirable
  • Experience in development and coaching
  • Excellent written and verbal communication skills essential.
  • Willingness to travel
For further information on this Senior Supplier Quality Engineer role in Galway please contact Bimi Felix on 0868395533 / bimi@hero.ie
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