Benefits:• A renowned leader in Medical Devices• Free membership at company gym• Flexible working hours• Competitive Salary PackageAbout the companyA distinguished Australian medical device company that manufactures and distributes a vast range of medical devices and surgical products. The company strives to offer innovative solutions to make a difference to patients' lives. They have a collaborative culture and pride themselves on their environmentally sustainable practices.About the opportunityAs a QA Associate you will be handling the audit program for internal and external audits and management of the computerized system reviews. You will also be tasked with oversight of validated processes and ensuring all issues and actions relating to the QMS are handled accurately and according to protocol. You will need to have strong attention to detail, good communication skills, the ability to work in a team environment and be proactive and have a forward-thinking mentality to streamline processes and pre-empt any issues with solutions.Duties• Assigning, reviewing, and monitoring audits to maintain certification with ISO13485 and ISO14001 standards.• Conducting internal and external audits in compliance with the organization's processes and procedures.• Analysing system gaps and implementing improvement programs.• Collaborating with external contract laboratories and sterilizer services organizations ensuring their documentation processes are in accordance with the organization's requirements.• Developing a cross-functional schedule for the validation and sterilization of processes and procedures within the organization.• Monitoring routine environmental and bioburden compliance.• Verifying the suitability of sterilized materials for release for sale.**Please note, the ideal candidate has unrestricted working rights in AustraliaSkills and Experience• Post-secondary qualification in a Science related field• Minimum 3 years of QA manufacturing medical devices experience or experience within in a similarly regulated industry.• Qualified internal auditor certification.• Minimum 2 years' experiencenof leading audits and writing well-structured reports.• Ability to work without constant supervision and continuous proactive team support.• Attentive to details, good communication skills, and great computer skillsCultureThis organization boasts a richly diverse and multicultural team, dedicated to nurturing a collaborative, supportive, and inclusive environment
