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Operations Quality Engineer

Job Title: Operations Quality Engineer
Contract Type: Permanent
Location: Galway
Industry:
REF: 94138
Job Published: 6 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 086 8395533


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

Key Job Responsibilities:
  • Overall responsibility for production GMP standards and compliance.
  • Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.
  • Establishing inspection standards, plans, frequencies and test methods.
  • Establishing and maintaining FMEA’s.
  • Preparing and updating Operations procedures and associated documentation.
  • Reporting area of responsibility metrics.
  • Supporting customer and surveillance accreditation audits.
  • The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
  • Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
  • Maintain relevant documentation to comply with quality standards and customer requirements.
  • Develop strong links with customer organisation’s and other project stakeholders.
  • Quality review of responsible area validation documentation.
  • 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.
  • Other duties as assigned from time to time.

Job Requirements:
  • Degree in Quality or Degree in Science / Engineering.
  • Experience within a similar role as quality engineer.
  • 5+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.
  • Working knowledge of FDA and ISO Quality systems for Medical device companies.
  • New product introduction and manufacturing process transfer experience would be a distinct advantage.
  • Quality experience in component and device manufacturing desirable.
  • Excellent written and oral communication skills essential.

For further information on role Operations Quality Engineer in Galway please contact Bimi Felix on 086 8395533 / bimi@hero.ie

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