Quality Operations Manager with quality operations management experience in a regulated sector required by growing medical devices multinational in Galway city. You will be responsible for driving  continuous improvement across fourteen production lines & for leading a team of 23 with 4 direct reports.

Responsibilities:

  • Ensure Health and Safety initiatives are successful and agreed targets are achieved
  • Lead and support the performance improvement program
  • Work with the business unit and Engineering Manager to achieve the Plant objectives
  • Develop Quality Operations Strategy for the business unit
  • Drive a Quality continuous improvement and innovation culture
  • Lead and support Cost of Poor-Quality initiatives
  • 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 (23 on the team with 4 direct reports)
  • 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

Requirements:

  • Level 8 Degree in Science / Engineering
  • 7+ years relevant Quality Operations experience in GMP Manufacturing environment in Medical Device/Pharma industry
  • Strong people management experience
  • Resilient, proactive and influential
  • Regulatory audit facing experience
  • 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 Standards
  • Ability to work as a proactive 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 problem-solving and innovation skills 

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

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