Quality Assurance
4 days ago
About Our Client
Our client is a global leader in medical device manufacturing, producing patient-specific implants. With headquarters in Germany, they are rapidly scaling their operations in Australia, launching a new production line in Sydney.
This is an exciting opportunity to join a fast-growing, cutting-edge manufacturing environment focused on innovation, quality, and safety.
Job Description
As the Quality Assurance & WHS Coordinator, you will play a key role in ensuring the highest quality standards and workplace safety as the company scales its manufacturing operations. This role has a strong focus on quality assurance with additional environmental health and safety (WHS) responsibilities.
Key duties include:
- Conducting daily QA activities in manufacturing, ensuring compliance with ISO 13485, TGA, and GMP regulations.
- Supporting production teams in quality-related matters, investigating issues, deviations, and nonconformances.
- Managing supplier-related quality incidents and driving continuous improvement initiatives.
- Ensuring compliance with EHS policies, monitoring workplace safety, and assisting with regulatory requirements.
- Conducting EHS inspections, risk assessments, and incident investigations.
- Providing training to operations staff on quality and safety procedures, fostering a strong quality and safety culture.
- Supporting internal and external audits and maintaining required documentation.
The Successful Applicant
- Quality Assurance experience within a manufacturing environment
- Knowledge of ISO 13485, TGA, GMP, and other quality standards is ideal
- Some experience or exposure to WHS/EHS responsibilities, with a willingness to develop further in this area.
- Background in manufacturing/FMCG environments
What's on Offer
- Career Growth - Join a rapidly expanding global medical devices company with strong potential for career progression.
- Work-Life Balance - 2 WFH days per month after probation, flexi-hours available.
- Extra Leave Benefits - Birthday leave, mental health & well-being leave, option to purchase two additional weeks of annual leave.
- Supportive & Innovative Work Culture - Work with cutting-edge 3D printing and medical manufacturing technology.
- Convenient Location - Free on-site parking in Sydney.
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