- North Ryde
- $40 - $50 per hour
- Job Type
- 6 months ago
- Global Organisation
- Market leading products
- Opportunity for growth
A well renowned med devices business are currently looking for quality assurance specialist to join their team on a 6 month full-time contract with a view to extend. The successful candidate will work collaboratively with and report to the Quality Directory & 2 Senior Quality Managers.
This person will be responsible for routine quality tasks, including
- Mail out all the patient cards within 2 WD upon receiving
- Follow up complaint enquiry questions with Sales rep and ensure no pending complaints in SFDC more than 24 hrs
- Register and deliver complaint samples within 2 WD upon receiving
- Perform product return inspection 1~2 times per week or per urgent business request
- Maintain Quality Q-hold log and manage Q-hold affected ANZ, including notifying SC/business stakeholders, notify 3PL for physical segregation and achieve Q-hold file
- Quality data analysis, including but not limited, complaint (hot issues), action tracking of FCA, Q-hold NCR and CAPA
Compile all the quality related records for the past 12 months, including but not limited to QMR, FCA, Q-hold and complaint, etc
- Experience in a quality and/or manufacturing environment in the medical device industry preferred
- Good organisational skills
- Ability to influence others in a positive manner
- Good interpersonal and presentation skills, able to work in a multicultural environment
- Proven expertise in MS Office Suite, Advanced Excel skills
- Excellent written and verbal communication skills
- Strong problem-solving and critical thinking skills.
- Knowledge of medical or pharmaceutical regulations as relating to documentation
- Understanding of medical devices regulations
- Strict attention to detail
- Ability to interact professionally with all organisational levels.
- Ability to manage competing priorities in a fast paced environment.
- Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness.
- Able to present information in an attention-getting and interesting manner
- Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control