This role combines hands-on quality assurance responsibilities with environmental health and safety oversight, ensuring manufacturing processes and products meet ISO 13485, TGA, and GMP standards. The successful candidate will support both operational excellence and workplace safety in a high-growth, scale-up environment.

Client Details

Our client is a well-established medical device manufacturer with a strong global presence and a growing operation in Sydney. Known for their commitment to precision, safety, and innovation, they are entering an exciting scale-up phase, with a new production line launching locally. The business fosters a collaborative and quality-driven culture, offering excellent development opportunities, flexible working options, and a supportive team environment.

Description

Conduct daily QA activities to ensure compliance with ISO 13485, TGA, and GMP standards.

Support the production team in managing quality issues, nonconformances, and deviation investigations.

Maintain quality documentation and assist with internal and external audits.

Develop, implement, and manage EHS policies and procedures in collaboration with the global EHS lead.

Conduct facility inspections, risk assessments, and EHS training to promote a safe, compliant workplace.

Support sustainability initiatives and promote a strong safety and quality culture across the team.

Profile

You'll be a self-motivated individual with experience in a regulated manufacturing environment, ideally within the medical device or pharmaceutical sector. A foundation in QA processes and an understanding of ISO standards is essential, while exposure to WHS or EHS compliance is highly advantageous. You'll have strong communication skills, a hands-on approach, and be eager to grow your career in quality and safety leadership.

Job Offer

Salary range of $80,000-$86,000 + super

Office-based in Sydney with 2 WFH days/month after probation

4 weeks of annual leave + option to purchase 2 additional weeks

Additional wellbeing and birthday leave

Flexi hours and free on-site parking

Exposure to new line setup and cross-functional collaboration with global teams

Career development in a company committed to quality, compliance, and employee wellbeing

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Henry Hall on +61 2822 181 12.