Senior Quality Assurance Engineer – Galway

An excellent opportunity to join a leading medical device organisation in a key role.

Key Responsibilities:

  • Collaborate with the project teams to facilitate the execution of the design services process and commercialization of new products.
  • Provide expertise in the areas of Quality Assurance, Design Controls, etc.
  • Development and approval of new product documentation.
  • Qualification of new suppliers/ requalification of existing suppliers.
  • Ensure that new medical device product development and changes to existing products are conducted in compliance with global regulations.
  • Participate in change review process for medical device products.
  • Contribute to process improvement efforts by developing and updating procedures and work instructions.
  • Develop and maintain documentation in compliance with FDA, ISO, MDD/MDR requirements.
  • Process customer complaints and manage customer replies.
  • Initiate non-conformance reports & lead root cause analysis investigations.
  • Champion continuous improvement through CAPA system.
  • Act as the QA representative for Supplier Quality management activities.
  • Represent QA as part of the Material Review Board.
  • Perform Internal and Supplier Audits.
  • Support Notified Body / Regulatory Agency / Customer Audits.
  • Collate and trend key performance indicator data.
  • Actively participate in management review & compliance meetings.

 

Requirements: 

  • BSc. in manufacturing engineering, quality engineering, life science or related.
  • 5+ years experience within the Medical Device Industry.
  • Proven record of handling multiple tasks simultaneously.
  • Proven record of policy and procedure development.
  • Must be highly motivated with excellent communication skills.
  • Act as a mentor to less experienced colleagues.
  • Quality Certification and Lead Auditor Certification advantageous.
  • Supplier Quality engineering experience advantageous.
  • Sterilization / Microbiology experience advantageous.
  • Some travel is a required.
  • Must be authorised to work in Ireland.

 

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

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