Quality Assurance & WHS Coordinator
About Our Client
We are a global leader in medical device manufacturing, producing patient-specific implants. With headquarters in Germany, we are rapidly scaling our operations in Australia, launching a new production line in Sydney.
Job Description
This is an exciting opportunity to join a fast-growing, cutting-edge manufacturing environment focused on innovation, quality, and safety as the Quality Assurance & WHS Coordinator. You will play a key role in ensuring the highest quality standards and workplace safety as we scale our manufacturing operations.
Key Responsibilities:
1. Ensure daily QA activities in manufacturing comply with ISO 13485, TGA, and GMP regulations.
2. Support production teams in quality-related matters, investigate issues, deviations, and nonconformances.
3. Manage supplier-related quality incidents and drive continuous improvement initiatives.
4. Evaluate compliance with EHS policies, monitor workplace safety, and assist with regulatory requirements.
5. Conduct EHS inspections, risk assessments, and incident investigations.
6. Provide training to operations staff on quality and safety procedures, fostering a strong quality and safety culture.
7. Support internal and external audits and maintain required documentation.
Requirements
1. Proven experience in quality assurance within a manufacturing environment.
2. Knowledge of ISO 13485, TGA, GMP, and other quality standards is desirable.
3. Some experience or exposure to WHS/EHS responsibilities, with a willingness to develop further in this area.
4. Background in manufacturing/FMCG environments.
What We Offer
1. Career Growth - Join a rapidly expanding global medical devices company with opportunities for career progression.
2. Flexible Work Arrangements - 2 WFH days per month after probation, flexible hours available.
3. Extra Leave Benefits - Birthday leave, mental health & well-being leave, option to purchase two additional weeks of annual leave.
4. Supportive & Innovative Work Culture - Work with cutting-edge 3D printing and medical manufacturing technology.
5. Convenient Location - Free on-site parking in Sydney.