Job no: 606093
Work type: Fixed Term Contract
Categories: Asia Pacific, Individual Contributor
Cochlear pioneered and is the global leader in the research and development, manufacture and marketing of implantable hearing solutions. Cochlear's global headquarters is located on the campus of Macquarie University to enable links to world leading hearing science research. A success story in the commercialisation of R&D, Cochlear has a 70% share of the global market, employs more than 2,500 people worldwide, operates directly in over 20 countries and sells in over 100 countries. Over 200,000 people across more than 100 countries now experience hearing as a recipient of a Cochlear hearing solution.
We are seeking a Quality Engineer to join our experienced team at our Brisbane manufacturing facility. In this position you will be supporting manufacturing activities whilst ensuring compliance to the companies quality management system.
In this role you will report to the Quality Manager. Your key responsibilities will consist of, but not limited to:
- Maintain compliance to Cochlear’s QMS to ensure adherence with ISO13485 and 21CFR Part 820 Quality Systems
- Support the Non-conformance (NCR) process with regular problem solving meetings to provide direction and guidance for stakeholders and assist in the implementation of the resulting corrective and preventative actions. Be the first point of contact for issues arising at the first time quality, fast response and morning market meetings.
- Release activities, including disposition of non-conforming material, the identification of scope, control of related NC material, root cause and appropriate CAPA actions and thorough documentation
- Work with cross functional teams to introduce new products into manufacturing. Work with project team members to establish process controls and provide Quality input into new product development, process improvements and change control.
- Ensure that appropriate quality plans, test methods, test plans, validation and risk (FMEA) documentation, are all in place and being adhered to during product development.
- Collate and present quality metrics, identify trends and opportunities for improvement.
- Work in conjunction with internal work groups such as Procurement and Design and Development to evaluate and develop suppliers to ensure they have the competency and capability to follow Cochlear Quality System requirements and meet product specifications.
- Active participation with site Quality and Audit support teams for 3rd party external audits.
- Communicate clearly and concisely within cross functional development teams; maintain and build relationships with internal and external stakeholders.
- A primary degree in a Science/Engineering discipline
- Minimum of 2 years’ experience in an engineering and/or quality role.
- A strong ability to communicate, present and report to various levels of the organisation.
- Demonstrate problem solving skills and process change/implementation.
- Knowledge of the medical devices industry ideal but not essential.
- Excellent interpersonal and communication skills and high level of computer literacy.
- Experience in the preparation of Technical Documentation
Cochlear can offer:
- A high impact job - making a difference to the quality of peoples' lives.
- Work with a global leader in active implantable medical device hearing technology.
- An opportunity to play a key role to deliver on our brand promise of "Hear Now. And Always".
Advertised: E. Australia Standard Time
Applications close: E. Australia Standard Time
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