Quality Engineer

Job Overview

FRS Recruitment are partnering with our client, a leading manufacturing company in the medical technology sector.

A fantastic opportunity has arisen for an experienced Senior Quality Engineer to join our Quality Management team in our Cork facility. This newly created role will be responsible for providing support to customers to ensure on-going quality and act as a pivotal point between service, customer, engineering and production. This role focuses on customer related feedback and performs investigation, determines root causes and resolution for quality and customer issues in accordance with the company Quality Management System.

Responsibilities include, but are not limited to:

  • Review initial customer contact, evaluate and manage the complaint from investigation through to review and closure documenting in accordance with quality and regulatory requirements
  • Review and analyse post market data [product and installation] for statistical trends and improvements with the Service Department to understand any problems and decide when to appropriately escalate issues working with engineering, supplier quality and manufacturing engineering.
  • Collect root cause analysis data and provide corrective feedback to quality issues
  • Ensuring that the products produced meet quality standards required to minimise quality costs and maximise customer satisfaction whilst ensuring that procedures and processes are adhered to
  • Support new product introductions with quality complaint data as an input into the design phase
  • Assist with new product or changes related to current products representing the customer and support in the development and refinement of design and process
  • Develop and implement practices that emphasise defect prevention, reduction in variation and waste and provide for continuous improvements in meeting all customer requirements
  • Train and guide teams in identifying and developing problem solving methodologies to resolve quality issues
  • Perform process related audits and improve the quality management system based on audit results including a focus on product quality customer complaints
  • Review final quality control procedures with a customer focus/product quality in mind
  • Review service bulletins related to complaint investigations
  • Keep up with current and developing manufacturing and engineering trends that concern the customer's product

To be successful in this role, you will have:

  • Bachelor's Degree in Engineering (Mechanical or Electrical focus desired), applicable Technical Field or documented and proven equivalent experience
  • 3+ years of experience in a regulated manufacturing industry working in Quality Assurance
  • Previous experience in a similar role within Medical Device Manufacturing would be highly regarded
  • Working knowledge of FDA, GMP, ISO 13485, and/or ISO 9001
  • Demonstrated experience in dealing with customers and complaints and a good understanding of customer expectations and deliverables with an awareness of the impact of failure/cost of poor quality
  • Demonstrated ability to understand and comply with applicable industry regulations and follow company operating procedures, policies, and rules is essential
  • Risk management experience is desirable
  • Strong analytical and statistics skills coupled with the ability to work on own initiative

If you wish to join a dynamic and growth focused business then please apply. For additional information about this position, please contact Leo Cordingley on 086 049 5443 via phone or text. Please also share with friends

Keywords: Quality Engineer, QA, Quality Assurance

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