Responsibilities :Support development, implementation and maintenance of the Genea Biomedx QMS.Review and maintenance of QMS records.Writing QMS documentation including standard operating procedures, work instructions, policies, related forms and templates.Administration of the training system.Assist with internal and external audits, ensure compliance with audit.Assist with supplier review and approval programs.Investigation and execution of CAPA’s, Change Control, Change Requests and other associated tools.Review of environmental monitoring results.Release of inwards goods.Review and approval of batch documentation, logs, test results, C of A’s and related documents for batch release and shipment.QA sign-off for release of product to market.Support calibration, maintenance and validation activities.Ensure departmental compliance with standard operating procedures, work instructions and policies.Batch record review, maintenance and storage.WHS Responsibilities :Operate within the scope of WHS requirements.Work with WHS representatives to integrate WHS with the QMS where feasible.Required Skills :Excellent oral and written English with ability to communicate at all levels internally and externally.Initiative, accuracy and attention to detail.Excellent work ethic and organisational skills.Ability to participate as an active team member and work independently.Ability to adapt to a fast-paced environment with frequent deadlines.Required Experience :Experience within a regulated, technical environment.Required Qualifications :Appropriate science qualifications (Bachelor’s degree in a scientific discipline).Seniority Level : Entry levelEmployment Type : Full-timeJob Function : Quality AssuranceMedical Equipment Manufacturing
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