Quality Assurance Officer

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

For close to 40 years Multigate has mastered the growing complexity of Australian Healthcare. By combining the professional competence of a multi-national company with our family-owned company’s virtues and values, we have successfully asserted ourselves within the Australian and International healthcare Industries.

We are currently seeking a Quality Assurance Officer to join our team located in our new state of the art facility in Yennora. The role will report to the Senior Quality Manager and is responsible for ensuring document, processes and systems relating to the manufacturing of products at Multigate comply with published specifications and customer expectations.

Role & 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

Qualifications and Experience:

• Demonstrable experience in an equivalent quality role within the medical device, pharmaceutical, manufacturing or similar industry


• Proven track record in implementing and maintaining ISO 13485-compliant QMS


• Demonstrated success in managing compliance and quality systems


• Hands on experience with:


• ISO 13485 QMS ownership


• Regulatory submissions or ARTG support


• Sterile or Class II/III devices


• Familiarity with risk management, document control, and audit processes under ISO standards and strong understanding of global medical device regulations (e.g., TGA, APVMA, MDR, MDD)


• Competency to read, write and independently interpret quality system documentation including batch documentation, material specifications, test records and quality system standards


• Excellent proactive problem solving and written and verbal communication skills


• Diploma/Bachelor’s degree in a STEM related or manufacturing preferred

Supportive and collaborative environment

Free onsite gym and parking

Close to public transport including Yennora train station