QA 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.

• Specific Responsibilities

• Manages approved supplier list in collaboration with the Procurement department, focusing on ensuring supplier compliance with applicable Medical Device regulations.

• Identifies and risks rate suppliers based on established SDI supplier management policies.
• Conducts supplier audits in collaboration with Procurement department, focusing on ensuring supplier compliance with applicable Medical Device regulations.
• Liaises with Supplier to ensure updates to products and raw materials are communicated in a timely manner to SDI.
• Maintains the compliance and completion of Supplier Agreements.
• Represents Quality Assurance in Change Control meetings related to supply changes for e.g., new/alternate supplier, changes to raw material specifications, update to standards.
• Supports Procurement department in onboarding alternate suppliers.
• Routinely reviews and updates the Assessment of Supplier and Purchasing procedures to ensure compliance with Regulatory requirements.
• Supports the upkeep of technical files for externally manufactured medical devices.
• Ensures all activities are performed in compliance with internal Quality System procedures and international/national regulations.
• Innovates improvements to Supplier Management procedures.
• Represents the QA department during audit of Supplier Management clauses.
• Supports demonstration of the suitability, adequacy, and effectiveness of the quality management system through the collation and analysis of supplier performance.
• 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.
• Maintains familiarity with SDI's current Quality policy and objectives

Key Relationships (internal and external)

• Quality Personnel
• Procurement Teams
• Suppliers
• R&D personnel
• Production personnel
• External Consultants

Job Environment

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

Essential Qualification/ Experience

• Holds a degree in relevant scientific discipline, ideally Electrical/Electronics Engineering etc.
• Strong knowledge in IEC regulations.
• 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.

Essential Skills, Knowledge and Attributes

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 and suppliers
• Flexibility
• Loyalty

Knowledge and Skills

• Aware of SDI's current Quality policy and objectives
• Strong communication skills
• Strong relationship building skills
• Stakeholder management
• Technical Competency
• Able to follow written procedures
• Problem-solving skills
• Friendly and customer-focused

If you are interested in this role, please click Apply now

Desired Skills and Experience
* Aware of SDI's current Quality policy and objectives

* Strong communication skills

* Strong relationship building skills

* Stakeholder management

* Technical Competency

* Able to follow written procedures

* Problem-solving skills

* Friendly and customer-focused