We are seeking an experienced Quality/Mechanical Engineer to support continuous process improvement initiatives, identify areas for enhancement and implement effective solutions. About Us Steritech is the leading and trusted contract sterilisation and decontamination processor in the Asia-Pacific region, and one of the largest worldwide. With operations in Victoria, New South Wales and Queensland, we provide Irradiation and ETO Gas processing services to the Agricultural, Fresh Produce, Healthcare, Biosecurity, Pet Products and Packaging industries. We are a customer and employee focused business that provides clients with unique opportunities to open their business to new markets through innovative, technically advanced solutions. About Your Role You will be responsible for: Ongoing compliance with relevant legislation and standards governing our business, sterilisation and manufacturing operations. Studying and maintaining detailed reports and statements of quality assurance, quality control and process operational activities. Establishing standards and policies for installation, modification, quality control, testing, inspection and maintenance according to engineering principles. Maintaining the site’s products, components and equipment and process inspection, calibration and preventative maintenance programs. Ensuring compliance with safety and regulatory standards and driving continuous improvement initiatives. Assist in specification control and developing specifications, incoming QC and inventory monitoring of critical process consumables. Preparation of processed loads for dispatch and validation documentation. About You You will have a minimum 2 to 3 years’ experience in a quality function within a pharmaceutical, manufacturing, general healthcare or other highly regulated industry. You will have: Qualifications in Mechanical Engineering or related discipline. Awareness of the general principles of sterilisation, validation, GMP manufacturing and related microbiology (desirable). 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. Sound judgment and decision-making abilities, often under pressure. Solid level of attention to detail. Effective communication skills and the ability to collaborate with internal teams and external stakeholders. To submit your application please do so by clicking the “Apply for this job” link and submitting your current resume. We will accept applications from all people with the right to live and work in Australia. Please note applications may be short-listed and progressed prior to the closing date.
Visit engineeringsuper.com.au to find our PDS and TMD.