We are a Global Business leading the market with Australian made and owned dental restorative products, teeth whitening and small equipment.
Founded in 1972, SDI products are now distributed in over 100 countries throughout the world.
Our global head office and manufacturing plant is located in Melbourne with overseas branch offices and warehousing in the USA, Brazil and Germany.
The Quality Assurance Associate is responsible for:
Supporting the quality department in the maintenance, management, and improvement of the company's quality management system.Monitoring the Customer Complaints database to ensure compliance with regulatory requirements and SDI policies.Supporting the timely completion of post market surveillance activities.Supporting the demonstration of the suitability, adequacy, and effectiveness of the quality management system through the collation and analysis of quality data.Conducting work in a safe manner and demonstrating a strong commitment to SDI's values of passion, accountability, respect, teamwork, and innovation.Specific Responsibilities: Reviews each complaint to ensure all required fields are appropriately filled and all actions completed before officially closing out the complaint.Identifies and manages potential reportable customer complaints to ensure proper timely handling of associated actions and closure.Conducts Post Market Surveillance, compiling and presenting Post Market Surveillance Report and Periodic Safety Update Report.Conducts statistical data analysis on key monitoring and measurement data such as Customer Complaints, Non-Conformances, CAPAs, etc.Routinely reviews and updates the Complaints and Quality Data Analysis procedures to ensure compliance with Regulatory requirements.Ensures all activities are performed in compliance with internal Quality System procedures and international/national regulations.Innovates improvements to Complaint Handling and Quality Data Analysis procedures.Supports audit response for Complaints Handling and Quality Data Analysis.Handles routine tasks timely and accurately.Qualifications: Holds a degree in relevant scientific discipline, i.e., Science or Engineering.Basic knowledge about Medical Device industry standards, including ISO13485, EU MDR desirable.3 years' experience in Quality Assurance desirable.Basic knowledge about industry GMP/GDP desirable.Proficient in MS Word, Excel, MS Project, and other computer software.Able to summarise and easily explain complex situations.#J-18808-Ljbffr