Care Essentials is an Australian medical device manufacturer. Our range of products includes patient warming machines/blankets, PPE including N95/P2 respirators, CSSD wraps, and other medical consumables. Our products are exported to over 70 countries.We are ISO 13485 accredited and TGA, FDA, EU registered. This is a unique opportunity to join an innovative company to work in the Quality Assurance and Regulatory area.Your RoleAs a Quality Associate, you will assist the QA Manager in maintaining MDSAP, ISO 13485, MDR, and all other regulatory requirements while ensuring product quality is maintained.Your responsibilities will include:Assist in the preparation of SOPs, work instructions, and other quality documentation.Manage customer complaints, non-conformances, and CAPA processes.Conduct internal audits, assist with external and supplier audits, and participate in training.Perform quality checks of batch records and oversee the release process.Ensure equipment maintenance and calibrations are up to date.Assist with management reviews.Qualifications:Tertiary qualification in science or engineering.1-2 years’ experience with a quality management system is desirable. Fresh graduates with a strong academic background will also be considered.Experience in ISO 13485 is an advantage.Attention to detail, ability to work to deadlines, and willingness to learn.This is a hands-on role requiring working from the office. Applicants from the Greater Geelong area are strongly encouraged to apply. No recruitment agencies, please.How do your skills match this job?How do your skills match this job?Sign in and update your profile to get insights.Your application will include the following questions:Which of the following statements best describes your right to work in Australia?How many years of experience do you have in a quality assurance (QA) role?Researching careers? Find all the information and tips you need on career advice.
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