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Senior Quality Engineer

Job Title: Senior Quality Engineer
Contract Type: Permanent
Location: Galway
REF: 90843
Job Published: 10 months ago

Job Description

Contact: Bimi Felix
Telephone: 0868395533

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

Duties & Responsibilities
  • Manage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISO13485, FDA QSR.
  • Coordinate the Internal Audit system and Audit Team to ensure that all audits are completed in a thorough and timely manner. Conduct Quality Audits as necessary.
  • Lead preparation and coordination activities for external audits and liaise as required with SME's to ensure audits are conducted in an efficient manner.
  • Manage all aspects of the Document Control Function in conjunction with the appropriate resources.
  • Responsible for generating Quality Performance data with the goal in identifying opportunities for improvements (CAPA).
  • Identifies any opportunities for improvement within the quality system procedures and practices in association with the appropriate internal groups.
  • Coordinate the Non-Conforming and CAPA system to ensure that all NC/CAPAs are completed in a thorough and timely manner.
  • Leading and managing investigations providing a formal structured approach to identify root causes, establish corrective actions and execute prevention plans in products and/or processes.
  • Use knowledge of statistics to assist with process improvements, validation developments and process/product investigations.
  • Assist with the development of suppliers to provide reliable, trustworthy and productive relationships
  • Perform supplier compliance and qualification functions and activities for prospective new Commodities, Purchased Finished Goods and Critical Service suppliers.
  • Perform supplier development activities with suppliers of defective materials including developing and executing Supplier Quality Plans, conducting "For-Cause" Audits, Supplier Corrective Action follow-up, coordinating Business Reviews, and implementing Six-Sigma and Continuous Improvement methods and techniques.
  • Resolve ineffective supplier corrective action plans with suppliers.
  • Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
  • Identify and initiate action to address any adverse trends or regulatory compliance issues in a timely manner.
  • Support the implementation of Company Policies and GMP
  • Provides additional support and assistance on tasks and projects as directed by management
Person Specification Overview:
  • The candidate will be experienced in developing; CAPA, NCMR systems and control plans ensuring that performance and product quality conforms to company SOP's, customer and regulatory guidelines. This is a lead role and will require the candidate to have people management experience.
Education & Experience Required:
  • Degree in Science or Engineering or similar technical discipline.
  • 7+ years' experience in Quality function, of which 3+ years experience in a Quality Engineering role with medical devices in FDA regulated environment.
  • Strong working knowledge of Quality Management Standard
  • Proven experience of Lean manufacturing / six sigma is highly desirable.
  • Lead Auditor certification desirable
For further information on this Senior Quality Engineer in Galway please contact Bimi Felix on 0868395533 /
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