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Senior Quality Engineer – Operations

Job Title: Senior Quality Engineer – Operations
Contract Type: Permanent
Location: Galway
REF: 96301
Job Published: 4 months ago

Job Description

Contact: Deirdre Finnerty
Telephone: 086 3073779

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

Major Accountabilities:
  • Lead and drive QA initiatives within area of functional responsibility.
  • Provide quality input and support to the manufacturing, engineering, prototype and commercial functions.
  • Lead and coordinate preparing & on-going maintenance of FMEAs and Control Plans.
  • Investigating root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.
  • Strategically lead new product introduction and contract reviews from a QA perspective.
  • Preparing and updating Operations procedures and associated documentation.
  • Overall responsibility for functional area GMP standards and compliance including the promotion of Quality Awareness.
  • Establishing inspection standards, plans, frequencies and test methods.
  • Reporting functional are Quality metrics.
  • Preparation of Quality reports for Operations meetings and management reviews.
  • Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements
  • Develop strong links with customer organisations and other project stakeholders.
  • Understanding of standard metrology good practice.
  • Quality review of functional area validation documentation.
  • Performing and 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.
  • Support Operations area projects and initiatives i.e. Kaizen, CFPS etc.
  • Supervision and direction of Quality personnel.
  • Other tasks as directed by the Operations Quality Manager in line with company goals and objectives.

  • Degree in Science / Engineering or related fields essential.

  • 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.
  • New product introduction and manufacturing process transfer experience desirable.
  • Demonstrated excellent organizational skills and ability to work on own initiative essential.
  • Supervisory experience desirable.
  • Excellent written and verbal communication skills essential.

For further information on this Senior Quality Engineer – Operations role in Galway please contact Deirdre Finnerty on 086 3073779 /

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