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.
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. You will be part of a collaborative team with the opportunity to make a measurable impact.