Quality Assurance

4 days ago


Willoughby City Council, Australia Michael Page Australia Full time
Quality Assurance & WHS Coordinator

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:

  1. Conducting daily QA activities in manufacturing, ensuring compliance with ISO 13485, TGA, and GMP regulations.
  2. Supporting production teams in quality-related matters, investigating issues, deviations, and nonconformances.
  3. Managing supplier-related quality incidents and driving continuous improvement initiatives.
  4. Ensuring compliance with EHS policies, monitoring workplace safety, and assisting with regulatory requirements.
  5. Conducting EHS inspections, risk assessments, and incident investigations.
  6. Providing training to operations staff on quality and safety procedures, fostering a strong quality and safety culture.
  7. Supporting internal and external audits and maintaining required documentation.

The Successful Applicant

  1. Quality Assurance experience within a manufacturing environment
  2. Knowledge of ISO 13485, TGA, GMP, and other quality standards is ideal
  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's on Offer

  1. Career Growth - Join a rapidly expanding global medical devices company with strong potential for career progression.
  2. Work-Life Balance - 2 WFH days per month after probation, flexi-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.
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