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QA Associate
4 weeks ago
SDI is a global business specialising in dental restorative products, teeth whitening and small equipment. Founded in 1972, SDI products are distributed in over 100 countries. The global head office and manufacturing plant are in Melbourne, with overseas offices and warehousing in the USA, Brazil and Germany.
Responsibilities- Manages approved supplier list in collaboration with the Procurement department, focusing on ensuring supplier compliance with applicable Medical Device regulations.
- Identifies and rates suppliers based on SDI supplier management policies.
- Conducts supplier audits in collaboration with Procurement to ensure compliance with Medical Device regulations.
- Liaises with suppliers to ensure timely updates to products and raw materials are communicated to SDI.
- Maintains compliance and completion of Supplier Agreements.
- Represents Quality Assurance in Change Control meetings related to supply changes (e.g., new/alternate supplier, changes to raw material specifications, update to standards).
- Supports Procurement in onboarding alternate suppliers.
- Routinely reviews and updates supplier and purchasing procedures to ensure regulatory compliance.
- Supports the upkeep of technical files for externally manufactured medical devices.
- Ensures activities comply with internal Quality System procedures and international/national regulations.
- Innovates improvements to Supplier Management procedures.
- Represents the QA department in audits of Supplier Management clauses.
- Supports demonstration of the Quality Management System's suitability, adequacy, and effectiveness through supplier performance analysis.
- Handles routine QA tasks timely and accurately.
- Supports Quality in maintaining and improving the company's Quality Management System (QMS).
- Assists Quality in ensuring compliance with ISO13485, MDSAP, EU MDR, and other applicable regulatory requirements.
- Maintains familiarity with SDI's Quality policy and objectives.
- Holds a degree in a relevant scientific discipline, ideally Electrical/Electronics Engineering, etc.
- Strong knowledge of IEC regulations.
- Working knowledge of Medical Device industry standards and regulations such as ISO13485, MDSAP & EU MDR.
- 3+ years' experience in Quality Assurance is desirable.
- Basic knowledge of GMP/GDP desirable.
- Proficient in MS Word, Excel, MS Project, and other software.
- Able to summarise and explain complex situations clearly.
Personal Qualities
- Analytical mindset
- Attention to detail
- Team-oriented; able to work under pressure
- Flexible and adaptable
- Good work ethic; eager to learn
- Highly self-motivated; collaborative with co-workers and suppliers
- Flexible and loyal
Knowledge and Skills
- Aware of SDI's Quality policy and objectives
- Strong communication and relationship-building skills
- Stakeholder management
- Technical competency
- Able to follow written procedures
- Problem-solving skills
- Friendly and customer-focused
- Location: Bayswater
- Working hours: 38 per week
- Local travel as required
- Quality Personnel
- Procurement Teams
- Suppliers
- R&D personnel
- Production personnel
- External Consultants
- Seniority level: Associate
- Employment type: Full-time
- Job function: Quality Assurance
- Industries: Manufacturing
If you are interested in this role, please click Apply now
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