Quality Assurance and Compliance Specialist
3 days ago
-Requisition Number APAC04950 Employment Type Full-time Location Sydney, New South Wales **About the Role** - **Global brand at the forefront of medical device & orthopaedic technology**: - **Full Time Role Belrose, NSW based with Hybrid Work.**: - **Attractive Base + 10.5% Super + Flex + Bonus**: - **ISO 9001 & ISO 13485 (13485 knowledge advantageous but not mandatory)** **About You** - Previous experience dealing with ISO 9001 requirements - if you also have familiarity with ISO 13485 that is a bonus but not required. - Demonstrated experience within a Quality Assurance role previously requiring QMS of supplies/distributors. - Ability to manage, effectively implement and promote QMS processes within the organisation as well as its suppliers and distributors. - Prior experience with receiving and processing post-market complaints/product issues. **About the Responsibilities**: - This role is responsible for overseeing all aspects of QMS and processes across ANZ, supporting the RAQA Manager. - Role focuses on establishing audit, repackaging/release, product recalls/issues across direct channels as well as with our distributors and suppliers. - You will have major involvement with monitoring our distributors and suppliers and ensuring their practices are in compliance with regional and global stands. - Supplier quality, compliance audits, warehousing and service centre operations all fall within your purview as well for involvement. - Handle product recalls and communicate with TGA/Medsafe - Provide complaints training and handling to staff members - Performance of internal and external QMS audits. - Deliver training to other QA staff on as needs basis. **About Us** As the leading innovator in musculoskeletal healthcare, our cutting edge robotics technology, interactive digital platforms, and comprehensive portfolio of products for joint reconstruction, bone and skeletal repair, sports and spinal injuries, help restore mobility, alleviate pain, and improve the quality of life for patients. Collaborating with top healthcare professionals around the globe to speed the pace of innovation, and expand the possibilities for successful treatment outcomes, Zimmer Biomet remains committed to our promise to look beyond what’s possible now, and discover what’s possible next. **_Applicants MUST be eligible to live and work in Australia._** To be considered, click "**Apply**" and include a current CV. For more information about this opportunity, please contact **Matthew Lineham** on** **0438 127 309**.
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