Quality Coordinator ANZ (part-time: 3 days/week)
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.
Benefits and Highlights:
* Attractive Basic Salary and Bonus
* Annual cash allowances for health insurance & wellness
* Excellent leadership, mentoring support with ongoing training & development
* Great reward and recognition programs
* Onsite parking provided and Company lunch days
* Part Time: 3 days per week (Mon/Tue/Fri)
About the role:
Support the Quality Manager in delivering key quality activities across ANZ. Ensure compliance with corporate quality standards impacting regional operations and products. Responsibilities include documentation control, post-market surveillance, and managing corrective and preventive actions (CAPA).
Essential Duties and Responsibilities:
* Maintains document management system for ANZ document control ensuring accuracy and completeness as well as document security, (INCL: Follow ups, Change Requests and Reviews)
* Performs quality related activities such as complaint management entries and maintenance, (INCL: Customer Response Letters and Ad Hoc Post Market Surveillance activities)
* Administrative functionality as required for Field Action, Non-Conformance & CAPA processes
* Trend internal quality data
* Participate within internal Quality improvement Projects.
About the Requirements:
Education and Experience:
* Bachelor's Degree required, preferably in a Science or Engineering discipline.
* 2 years of direct experience in administration of quality system elements within a medical device organization within the ANZ market
Knowledge and Skill Requirements/Specialized Courses and/or Training:
* Knowledge and a clear understanding of TGA, MEDSAFE regulations preferred.
* Working experience in implementation and maintenance of the ISO 13485:2016 standard
* Excellent and proven interpersonal skills
* Strong interpersonal, English oral and written communication skills required.
* Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams).
* Comprehension of orthopaedic technical/engineering/medical terminology or can reference literature for understanding.
* Ability to work independently and as part of a team.
* Attention to Detail: Meticulous in documenting and following up on complaints and maintenance issues.
* Team Player: Collaborative and able to work well with colleagues across different departments.
* Adaptable: Flexible and able to manage multiple priorities in a fast-paced environment.
About Arthrex
Arthrex is a global medical device company and leader in new product development and medical education in Orthopaedics. With a corporate mission of Helping Surgeons Treat Their Patients Better, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. We are a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.
Great Place to Work Certified 2025/2026:
Arthrex Australia and New Zealand is proud to be Great Place to Work Certified based on feedback from our dedicated and growing team. We are renowned in our industry for our positive culture, integrity, leadership, and inclusivity. Join us at Arthrex, where your career can truly thrive.
Applicants must have full Australian work rights to be considered at this time.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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