Quality Engineer

Your responsibilities

As a Quality Engineer you will be a key member of the Quality Department. Principle tasks will include: :

  • Compiling metrics to demonstrate the effectiveness of the Quality Management System
  • Creating and revising quality procedures and forms
  • Managing the Deviation (Non-Conforming Report (NCR)) system in line with corporate requirements
  • Establishment or review of records established through NCR’s , Deviations, CAPA’s, Change Controls and customer complaints
  • Participate in cross functional teams in dealing with NCR’s, Deviations,Change Controls, CAPA’s and Complaints
  • Performance of audits (internal audits and supplier)
  • Reviewing and approving protocols and reports associated with process validation and qualification of new equipment
  • Provide QA support to Procurement process, when assessing and qualifying Vendors
  • Share expertise and knowledge with other QA Representatives
  • Promote and support quality, compliance and validation activities

Your qualifications

  • A level 7 degree in a Science or Engineering discipline or equivalent experience in the Medical Device Sector
  • Excellent working knowledge of Quality System Requirements such as ISO 9001 and ISO 13485.
  • Knowledge of FDA compliance
  • Minimum 4 years experience working in the Quality Department of a Medical Device / Pharmaceutical or Healthcare company.
  • Strong communication and problem solving skills
  • Effective communication skills required to support cross-functional team activities
  • Ability to work independently and as part of a team; Ability to multi-task in a high-paced environment

Your Recruitment Consultant is Sean Winstanley

Sean Winstanley
Sean joined Arcon Recruitment in early 2018 as our Specialist Technical Recruiter. Originally from the UK, now settled in Ballaghadrereen, Sean brings a wealth of recruitment experience in the IT / Technical arena. Sean has developed excellent skills account managing international, high profile clients solving their recruitment dilemmas.