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Quality Improvement Specialist

2 weeks ago

Limerick, Limerick, Ireland Life Science Recruitment Full time

We are currently recruiting for an exciting opportunity with a leading medical device organization based in Ireland.

This is an excellent position for anyone looking to join a multinational company that excels in its field.

Key Responsibilities:

  • Develop and execute plans to continuously improve and optimize product quality and process yield.
  • Use process characterization and optimization techniques, problem-solving tools, and decision-making strategies.
  • Identify and implement process-related continuous improvement activities to enhance product quality and increase Overall Equipment Effectiveness.
  • Maintain the Quality Management System requirements (ISO 13485, FDA & JPAL).
  • Lead by example and demonstrate a clear work ethos within the team.
  • Collaborate with personnel to resolve Corrective/Preventative actions addressing Quality, Technical, and Manufacturing issues.
  • Plan, deliver, and report on project outcomes accurately and on time.
  • Participate in risk assessments and HAZOPs of manufacturing processes and equipment.
  • Develop and maintain Behavioural Standards in line with company standards and policy.

Requirements:

  • Primary Degree (Level 8) in Process, Production, Manufacturing, Polymer, Materials, Biomedical, or Mechanical engineering.
  • Minimum 4 years' experience in manufacturing and validation in a regulated environment.
  • Relevant experience with statistical process control and capability analysis.
  • Strong analytical and problem-solving skills, root cause analysis, and risk assessments.
  • Familiarity with manufacturing and validation in a regulated (FDA or IMB) environment.