QA Lead — ISO 13485 Medical Devices

Multigate Medical Products Pty Ltd; Sydney; On-site; AUD 80,000 - 110,000; Full time

Benefits offered by this job

Free onsite gym and parking

Close to public transport

Job summary

Multigate Medical Products Pty Ltd is seeking a Quality Assurance Officer for our advanced Yennora facility in NSW. You will ensure QMS documents, processes and systems meet specifications and customer expectations under the guidance of the Senior Quality Manager.

The role covers risk management, CAPA, change control, and regulatory submissions support across local and international operations, with training responsibilities and a focus on continuous improvement.

Qualifications

• Experience in a quality role within medical devices or related manufacturing industry.
• Proven track record implementing ISO 13485-compliant QMS.
• Familiarity with TGA, APVMA, MDR/MDD and global medical device regulations.
• Ability to read and interpret quality system documentation.

Responsibilities

• Confirm the completeness and accuracy of QMS documentation and vendor published specifications.
• Undertake performance review of materials and samples associated with local and international suppliers.
• Maintain assigned aspects of ISO 13485 certification and ensure audit readiness.
• Provide training and guidance on quality and regulatory compliance.
• Support semi-quantitative risk management and CAPA processes.
• Undertake qualification activities associated with critical production processes and supervise the processing of change control workflows.
• Assist the Quality team with the implementation of Quality and Environmental Management Systems and drive continuous improvement projects.

Skills

Problem solving

Communication skills

Attention to detail

Regulatory understanding

Team collaboration

Education

Bachelor’s degree in STEM or manufacturing

Diploma in related field

Tools

ISO 13485 QMS ownership

Job description

Multigate Medical Products Pty Ltd is seeking a Quality Assurance Officer for our advanced Yennora facility in NSW. You will ensure QMS documents, processes and systems meet specifications and customer expectations under the guidance of the Senior Quality Manager.

The role covers risk management, CAPA, change control, and regulatory submissions support across local and international operations, with training responsibilities and a focus on continuous improvement.