- Work for a leading Medical Device firm;
- Work as a specialist in the post market surveillance team;
- Long term contract opportunity;
Our client is the market leader in the Medical Device sector with a large international footprint. They currently have a long term contract opportunity or a QA to work as a Post Market Surveillance Specialist. If you are looking for an opportunity that will stand out in your portfolio then don't miss out.
- Timely reporting and obtaining approval from competent authority of any notification related to product safety/ regulatory non-conformance issues or product performance issues.
- Customer Feedback and Event Reporting Management-supporting with handling customer feedback & complaint/field related issues.
- Provide support with maintenance of ANZ Quality Management System (QMS), via the document control process, and supporting activities related to Non Conformance, Process Improvement and CAPA (Corrective Action and Preventive Action) processes.
- Execution of reporting Field Safety & Customer Information notices as part of the Corrections & Removals process, and weekly/ monthly reporting to Quality Manager- ANZ.
- Supporting the business in timely implementation of field change orders relating to safety & product performance issues.
- Following relevant quality procedures in order to deliver quality products and services, identify and support the implementation of continuous improvement activities.
Qualification & Experience:
- Ideally, Engineering/Science tertiary qualification with working knowledge in complaints/ post market surveillance within a Medical device environment.
- 2- 3 + years of experience in vigilance reporting, quality systems regulations and post market activities
- Preferably an understanding of ISO9001, ISO 13485, FDA QSR, TGA/ Medsafe and local ANZ laws.
- Strong background in data analytics and technical writing.
- Ability to work with local and international stakeholders in all levels.
Remuneration & Work Rights:
- Must have full work rights for Australia
- Salary - $85,000 - $95,000 + super
How to apply:
Apply online, feel free to give me call 72 hours after application has been made: Vern Myburgh - 0449 229 194
At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background....