Manufacturing Engineer - Quality Engineering

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.