We are one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Our products and services are available in over 100 countries around the world. We aim to help people lead more active and more satisfying lives.
We are looking for an enthusiastic positive senior QA Associate who is eager to learn and contribute.
You will work as part of QA Team to assist all tasks and functions of Regulatory Affairs / New Product Development / Formulating / QA systems.
About the role:
Lead internal and external audit activities to ensure trials are conducted in accordance with the protocols, Industry Guidelines and applicable Standards
Liaise with the team on technical issues including formulations, quality, stability
Support and encourage Continuous Improvement initiatives across Training and Best practice sharing
Provide mentoring and assistance to junior members of Quality team
Monitoring and reporting of quality activity ensuring management is informed in a timely manner of changes/trends that could affect SSPs quality system
Participate in developing SOPs and training courses as required
Skills and Experience Required:
5+ years’ experience in Medical Device Quality Systems, including operational experience
Knowledge of validation of equipment and processes
Experience in Good Document Practice (GDP), Document management and control
Experience in implementing and maintaining quality systems
Good communication skills and eager to learn
Work as a Team with Can-Do attitude and creative thinking
Preferable experience with ISO 13485, FDA, GMP (PIC/s), CMDCAS, MDSAP
Lead audit certification in ISO13485/9001 Quality System
Strong technical writing skills
Ability to work to strict deadlines
Self-motivated, committed & able to take initiative to deliver results
Ability to demonstrate strong customer focus and attention to detail
Able to travel as required by the business
Please feel free to email me directly on email@example.com
To apply online, please click on the apply button and attach your CV and Cover Letter preferably in Word format
Alternatively, for a confidential discussion, please contact Katie Stefanovic on +61 (2) 8249 4019 or 0401 908 007, quoting Ref No. 145906. Please continue to check our website for other positions available.