Key Responsibilities
* Maintain compliance with relevant legislation and standards in sterilisation and manufacturing operations.
* Monitor and maintain quality assurance, quality control, and process operational reports and statements.
* Establish engineering principles for installation, modification, quality control, testing, inspection, and maintenance standards and policies.
* Oversee products, components, equipment, and process inspection, calibration, and preventative maintenance programs.
* Ensure safety and regulatory compliance, driving continuous improvement initiatives.
* Assist in specification control and develop specifications, incoming QC, and inventory monitoring of critical process consumables.
* Prepare processed loads for dispatch and validation documentation.
About You
* You must have qualifications in Mechanical, Electrical, Biomedical, or similar Engineering, or equivalent experience.
* Awareness of general principles of sterilisation, validation, GMP manufacturing, and related microbiology is desirable.
* You should have a sound understanding of Good Manufacturing Principles and Quality Management System requirements (GMP PIC/S, ISO13485, ISO11137).
* Knowledge and experience in TGA Audits and/or other regulatory bodies are desirable.
* You will need sound judgment and decision-making abilities, often under pressure.
* Solid attention to detail is essential.
* Effective communication skills and collaboration with internal teams and external stakeholders are necessary.
The ideal candidate will possess strong analytical and problem-solving skills, be able to work independently, and be willing to learn and adapt to new situations. Steritech values diversity and inclusion and encourages applications from qualified candidates regardless of their background.
This role requires a high level of technical knowledge and expertise in engineering principles and practices. The successful candidate will be responsible for implementing and maintaining processes that ensure the highest quality standards are met.