25 April 2021
Located in Melbourne’s CBD and reporting to the Senior Quality Engineer, you will be responsible for monitoring and improving GK’s Quality Management System, Training Program and Product Development Process compliance within the regulatory requirements.
- Support the document control system including the monitoring of QMS documentation workflow, creation of new or draft documents and the review of documents for accuracy and compliance.
- Support the medical device and software design & development process including change control and validation activities.
- Participate in the review and update of Technical Documentation (Design and Product specifications, Validation documents, Principles of Operations, Risk Assessments, Manufacturing methods and specifications, Labels, etc) and other QMS related documents to ensure compliance with the Medical Device Regulation (EU), Therapeutic Goods Administration (TGA), ISO 13485 and 21 CFR Part 820.
- Review and investigate product/ process non-conformances, customer complaints and feedback.
- Facilitate the Corrective Action and Preventive Action (CAPA) system by reviewing and updating CAPAs, and supporting and training members of the team in conducting root cause analysis investigations
- Monitor, support and execute training programs.
- Support manufacturing activities by leasing with the contract manufacturer and other suppliers to resolve product/ process non-conformances.
- Conduct manufacturing batch record audits to ensure compliance with current procedures and standards.
- Support the collection and analysis of data for the Management Review and Quality meetings.
- Oversee the Supplier Management System to ensure supplier assessments, re-evaluations and audits are completed as required.
- Participate and support in internal, supplier and external audits.
You must have:
- Tertiary qualification in a related Science and/or Engineering field such as biomedical, biotechnology, manufacturing, chemical, etc.
- Minimum 4-5 years’ experience as a Quality professional in the Life Science industry (Medical Device industry preferred), operating in a GMP environment.
- Sound knowledge on ISO 13485, IEC 62304, TGA, EU Medical Device Regulations and FDA QSR 21CFR820
- Hands on experience with electronic management systems
- Demonstrated experience to proactively work unsupervised and drive initiatives to promote the enhancement of QA within the Company.
Sounds like you? Then we would love to hear from you.
Please send your CV and letter of application addressing the key selection criteria and outlining your experience via Recruitment.