Manufacturing Qa/Qc Officer

Proteomics International is an ASX listed medical technology company at the forefront of predictive diagnostics and bio-analytical services. The company specialises in the area of proteomics – the industrial scale study of the structure and function of proteins. It received the world's first ISO 17025 laboratory accreditation for proteomics services and also holds ISO 13485 laboratory accreditation. Proteomics International operates from state-of-the art facilities located at the Harry Perkins Institute of Medical Research on Perth's QEII Medical Campus.

Key Responsibilities

• Assist Manufacturing Manager in ensuring compliance with ISO 13485 requirements for QMS audit readiness
• Document control and change control activities
• Audit activities and trending of quality metrics
• Manage documentation and records related to manufacturing and quality assurance activities
• Investigate nonconformances, perform root cause analysis and implement CAPA
• Inventory management
• Assist in verification and validation activities
• Coordinate global shipments
• Assist in regulatory activities such as the preparation of regulatory documentation for product portfolio and post-market surveillance activities
• Assist in the development of new products to the Company’s diagnostic pipeline
• Liaison with cross functional teams, external manufacturing partners, suppliers and auditors

Qualifications, Experience and Skills

Essential

• Tertiary qualification in biotechnology, biomedical sciences, life/applied science or equivalent
• Relevant experience working with QMS from a QA and/or Manufacturing capacity within a highly regulated industry i.e. medical devices, IVDs or pharmaceuticals
• Excellent analytical abilities, strong communication skills, and effective attention to detail 
• Excellent organisation and administrative skills
• Excellent written and verbal communication skills

Desirable

• Familiar with medical device regulations and relevant ISO/IEC standards such as Australian TGA requirements, MDR, IVDR, ISO 13485, ISO 15189

High energy applicants who can multi-task and handle a fast-pace, dynamic work environment. Excellent communication skills, efficient time management skills, initiative and problem-solving skills are essential, as is the ability to clearly report on work activities. We require a motivated person with the ability to work within a team or on their own.

Opportunities and Benefits

• Supportive work environment
• Competitive salary (commensurate with experience)
• Career growth and development opportunities
• State-of-the-art facilities
• Great location

This position is being offered on a permanent, full time or part time basis. 

You must have work rights in Australia and the position is Perth based.

Additional enquires for this position may be directed to *******@proteomics.com.au 

We are a growing company in a rapidly changing market, and always looking for the right people to join our team. If that is you, please send us your CV. Applications close when a suitable candidate is found.

Please refer to www.proteomics.com.au for further company details.