Customer Quality Engineer

All vacancies of AustraliaManufacturing, Transport & LogisticsCustomer Quality Engineer

Newly created role; Outstanding opportunity to join our global, high-tech business.

Summary about this job

Quality Assurance & Control

Company: Ellex Medical Pty Ltd

Location: Adelaide

Work type: Full Time

Salary: n\a

Phone: +61-8-1536-9843

Fax: +61-8-4397-5439

E-mail: n\a

Site:

Detail information about job Customer Quality Engineer. Terms and conditions vacancy

Ellex Medical is a global, high-tech company with more than 30 years in the forefront of medical device technology. From its headquarters in Australia, Ellex designs, manufactures and sells a premium line of medical devices used to diagnose and treat eye disease. We are recognised as the global leader in ophthalmic laser technology and our devices are used by eye surgeons around the world. We have sales offices in the USA, France, Germany, Japan and Australia, and a network of more than 50 distribution partners around the world services other markets.

A fantastic opportunity has arisen for an experienced Customer Quality Engineer to join our Quality Management team in our head office. 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 Ellex Medicals’ 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
  • 5 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 14971
  • 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 Ellex and its products, please visit www.ellex.com

Note: We do not accept unsolicited CV’S from recruitment agencies/third parties.

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