Title:Quality Manager, ANZ
Responsible for all Quality related activities for ANZ. Manages the Quality Management System (QMS) and coordinates the daily quality activities in the region working closely with APAC Quality team. Maintains understanding and compliance to corporate quality requirements affecting regional company operations and products. Reports the performance of the quality system to relevant authorities and Arthrex Management as required. Areas of responsibility may include but are not limited to; Documentation Controls, Corrective Action Preventive Action (CAPA), Post Market Surveillance and QMS auditing.
Essential Duties and Responsibilities:
- Provides leadership, management, and development of the Quality Team (2),
- Establishes document management system for ANZ document control ensuring accuracy and completeness as well as document security.
- Collaborates effectively with QMS stakeholders across the organization to drive continuous improvement of the QMS and related processes.
- Ensures the effective implementation of processes across the ANZ.
- Manages and leads post-market regulatory activities such as complaint management, field actions, adverse event reporting in ANZ.
- Manage and schedule internal and external audits.
- Initiate internal corrective actions necessary to ensure overall quality compliance.
- Perform internal and external quality audits, issuing related corrective actions.
- Follow up on effectiveness of CAPA.
- Trend internal quality data and prepare management reports on quality metrics.
Location of work: this role is primarily based from our head offices in Frenchs Forest how there may be some occassional requirement to spend time at our warehouse and logistics facility at Arndell Park (once per week could be expected at this stage)
- Relevant people leadership experienece,
- Direct experience in administration of quality system elements within a similar role (e.g. leading quality management for another medical device organisation in ANZ),
- Knowledge and a clear understanding of TGA, MEDSAFE regulations,
- Working experience in implementation and maintainence of the ISO 13485:2016 standard,
- Knowledge of regulations in the areas of Quality System Requirements including topics such as CAPA, Auditing, and Document Control will be an advantage,
- Excellent and proven interpersonal skills,
- At least intermediate IT Skills e.g. Excel and various other relevant software programs,
- Strong project management skills,
- Ability to work in fast paced environment and handle multiple tasks and requests,
- Comprehension of orthopedic technical/engineering/medical terminology, or can reference literature for understanding,
- Bachelor’s degree qualified, ideally in a relevant discipline.
Why join Arthrex ANZ:
We are a global medical device company and leader in new product development and medical education in orthopaedics. Our corporate mission is Helping Surgeons Treat Their Patients Better™.
After more than 20 years in the region, Arthrex has moved to a direct-service model in 2021. We are genuinely excited about this development as we will be able to provide improved access to our innovative product range, medical education, networking and partnership opportunities.
This decision brings Arthrex in ANZ into-line with our direct businesses in the APAC region.
We have hired 170 new ‘Foundation Team’ employees throughout ANZ. This is an opportunity to work with a global-leader committed to the region.
The Arthrex culture is one of shared vision, innovation, diversity, historical success, and a passion for delivering outstanding services and products to our customers. Arthrex provides a collaborative work environment. Everyone who works for Arthrex has a voice. Growth opportunities are key to what we do at Arthrex, and we provide all our people opportunities to grow.
Our global employment plan is one of excellence, and we will provide a compelling employee benefits package.
Arthrex continues to experience unprecedented growth and demand for our products throughout the world; however, we remain 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.
Don’t miss this opportunity: apply now!
Note: every application is reviewed and every candidate will receive notification of the outcome of their application in a timely manner.
To find out more, or for a confidential career conversation, feel free to contact Ben Healan (Talent Acquisition Manager ANZ) on either Ben.Healan@arthrex.com.au or +61 (0)431 735 103.