Quality Operations Manager with Supplier Quality / Quality Operations experience required to drive continuous improvement at multinational medical devices multinational in Galway

Key Responsibilities:

  • Health and Safety – focus in line with plant objectives to ensure initiatives are successful and agreed targets are achieved including accident reduction and 5S+1 program success
  • Lead and support the program to achieve the star ratings through implementation of tools through the business, and drive performance improvements through the use of these tools
  • Develop Quality Operations Strategy for the business unit
  • Drive a Quality continuous improvement and innovation culture
  • Lead and support Cost of Poor Quality initiatives
  • Develop strong links with customer organisations
  • Ensure compliance to the Quality Management system in all activities
  • Participate in new product introductions to ensure quality is built into all products early in their life cycle
  • Ensure effective and efficient process controls are implemented and maintained (inspection standards, plans, frequencies and test methods)
  • Management and continued development of Quality staff
  • Promote awareness of the applicable regulatory requirements and Quality Management system requirements throughout the organisation
  • Develop and implement Manufacturing procedures and systems to assure product manufactured for human use meets design and functional specifications
  • Support regulatory agency and customer Quality audits. Act on behalf of Plant Management during audits
  • Ensure all aspects of the site QMS are managed and developed in line with regulatory standards, and ensure a culture of continuous improvement is in place to drive improved effectiveness and efficiency
  • Design and develop forms and instructions for recording, evaluating, and reporting quality data
  • Drive the utilization of formal problem-solving techniques to resolve process-related issues
  • As required, lead cross-functional teams to support resolution of product and/or process-related issues or objectives
  • Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as FDA QSR (21 CFR 820), ISO 13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD) Sch3/ MDD, MDR Standard

 

Requirements: 

  • Level 8 Degree in Science, Engineering or related subject
  • 5+ years relevant Supplier Quality / Quality Operations experience in GMP Manufacturing environment in Medical Device/Pharma industry
  • Ability to work as a team member
  • Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role
  • Good organization and investigation skills are required
  • Excellent communication skills

Please contact Emer Smith to discuss in confidence
00353578638188       
emer@emtechrecruitment.ie

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