At Carclo, we manufacture high-precision components for critical applications, including medical devices. Our Mitcham site operates in a highly regulated environment where quality and consistency are essential.
A high number of candidates may make applications for this position, so make sure to send your CV and application through as soon as possible.
We are looking for a Quality Engineer to support both new product introduction and ongoing production, driving robust quality processes through metrology, validation and data-led improvement.
Key Responsibilities
- Lead ISIR and FAIR activities for new tools and components
- Conduct capability studies and Measurement System Analysis (MSA)
- Support validation activities including IQ, OQ and PQ
- Perform and manage calibration activities in line with the schedule
- Analyse data and provide recommendations to Engineering and customers
- Verify jigs and Go / No Go gauges
- Produce and approve metrology and validation reports
- Support continuous improvement and quality system activities
- Represent Quality at internal and customer meetings
What You’ll Bring
- Experience as a Quality Engineer within manufacturing
- Strong understanding of statistical analysis (Cp, Cpk, Gauge R&R)
- Experience using non-contact and handheld measuring equipment
- Knowledge of validation processes and regulated environments
- Ability to interpret engineering drawings
- Strong communication and stakeholder management skills
Desired
- Experience within medical devices
- Knowledge of ISO 13485
- Experience with Minitab
- Understanding of injection moulding
Why Join Carclo
This a fantastic opportunity to join a business where quality is critical and the work you do directly supports the delivery of high-specification medical components. xwzovoh You will be part of a collaborative team with the opportunity to make a measurable impact.
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