Quality Assurance Associate

Company

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.

Summary of Role

• Monitoring the Customer Complaints database to ensure compliance with regulatory requirements and SDI policies.
• Supporting the timely completion of post market surveillance activities.
• Analysing quality data from various aspect of the Quality Management System and generating reports for management to review.
• Contributing towards SDI Strategic Priorities.
• Conducting work in a safe manner, adhering to quality compliance requirements and demonstrating a strong commitment to SDI's values of passion, accountability, respect, teamwork, and innovation.

Specific Responsibilites

• Reviews each complaint to ensure all required fields are appropriately filled and all actions completed before officially close out the complaint
• Identifies and manages potential reportable customer complaints to ensure proper timely handling of associated actions and closure
• Ensures customer issues are addressed by Sales/Customer Service Teams
• Supports QA team in conducting 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 the demonstration of the suitability, adequacy, and effectiveness of the quality management system through the collation and analysis of quality data
• Handles routine QA tasks timely and accurately.
• Supports the Quality department in the maintenance, management, and improvement of the company's quality management system (QMS)
• Assists Quality department in ensuring compliance with ISO13485, MDSAP, EU MDR, and any other applicable legal and regulatory requirements

Job Environment

• The position is located at Bayswater and Montrose in future.
• Working hours: 38 hours per week.
• Local travel as required.

Essential Experience

• Holds a degree in relevant scientific discipline, ie, Science or Engineering etc.
• Strong knowledge in reviewing and analysing device’s complaints.
• Experience in complaint handling, post market surveillance, quality assurance or medical device industry.
• Working knowledge of Medical Device industry standards and regulations such as ISO13485, MDSAP & EU MDR.
• 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 situation.

Personal Qualities

• Analytical mindset
• An eye for detail
• Team orientated
• Ability to work under pressure
• Flexible to adjust course when required
• Good work ethic
• Has an interest in learning
• Highly self-motivated
• Ability to work in harmony with co-workers
• Flexibility
• Loyalty

Knowledge and skills

• Aware of SDI’s current Quality policy and objectives
• Good communication skills
• Strong relationship building skills.
• Has a passion to develop new skills.
• Technical Competency
• Able to follow written procedures.
• Problem-solving skills
• Friendly and customer-focused