Lead Quality Engineer (Sydney, Australia based)
Job no: 605256
Work type: Permanent
Categories: North America, South & Central America, Asia Pacific, Oceania, Western Europe, Eastern Europe, Middle East & Africa
Cochlear is the global market leader in implant hearing solutions and is a top 100 company on the ASX. Cochlear's mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people's lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always.
We are seeking an experienced Lead Quality Engineer to lead the Manufacturing Quality Assurance team to ensure that products released from manufacturing are in conformance with specifications and regulatory requirements. This role is based in our Global Head office in Sydney, Australia
You will identify and champion continuous improvement of Quality Operations processes (NCRs, Concessions, CAPAs, Change Control) to consistently meet the on-going business needs.
You will thrive on mentoring and leading a close knit quality team and be passionate about quality. You will have proven knowledge and experience in a medical device manufacturing engineering environment.
Other accountabilities include:
- Ensure the release of high quality products from Manufacturing, which comply with specifications and regulatory requirements
- Ensure the appropriate levels of process controls, monitoring plans and reaction plans are in place via the Manufacturing Quality Plan
- Drive the performance metrics for non-conformances, and provide status update reports for CAPAs, audit findings, acceptance/release activities and process monitoring activities
- Supervise the local site manufacturing QA team
- Ensure the Quality Operations team are active in checking, identifying and ensuring all quality operational processes in Manufacturing are compliant to relevant standards
- Collaborate with key stakeholders as the quality subject matter expert
Why is this role right for you?
- You will be degree qualified in Engineering or Science and have proven experience in a medical device manufacturing engineering environment.
- You will have knowledge of and experience in providing guidance to manufacturing teams in the application of ISO 13485 and/or EN ISO 13484 and/or 21 CFR Part 820.
- With an engaging style and outstanding influencing skills, you will be an experienced people manager with significant experience in leading continuous improvement projects to quality processes.
We Reward Performance and Offer Flexible Benefits
To help us attract people with the right skills we aim to pay competitively in the health science and technology markets.
We offer flexible and adaptable benefits that you can tailor to suit your individual needs. Our flexible benefits include:
- Salary continuance insurance
- Salary sacrifice options
- Novated leasing
- Employee support services
- Cochlear Advantage employee discount program
- Educational assistance (conditions apply)
- Flexible work policy
If your skills and experience are in line with the position we look forward to hearing from you
Take the first step towards a career with Cochlear. A career you can be proud of. Please contact Emma Shannon, Talent Acquisition Specialist, Cochlear direct on email@example.com or +61 2 9611 6668 for further discussion or please apply via link.
Advertised: AUS Eastern Standard Time
Applications close: AUS Eastern Standard Time
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