Overview
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 distributed in over 100 countries. Our global head office and manufacturing plant are in Melbourne with overseas branch offices and warehousing in the USA, Brazil and Germany.
Responsibilities
* Ensuring the quality, legal and regulatory compliance of SDI products throughout their lifecycle, from design and development to manufacturing to distribution.
* Overseeing the implementation and maintenance of a robust quality management system (QMS) in accordance with current standards and regulatory requirements (e.g., ISO 13485, MDSAP, EU MDR, QMSR US, ARGMD AU, ANVISA Brazil, KGMP/MDM&QC SK, NMPA China, Health Canada, PMD Act Japan).
* Accomplishing quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures.
* Contributing to the development and implementation of Quality systems, policies and strategies.
* Maintaining safe work practices and upholding SDI values: passion, accountability, respect, teamwork and innovation.
* Leading, coordinating, and planning the work within the QA team; coaching and developing QA staff.
* Maintaining accurate, up-to-date QMS documentation, including procedures, records and reports.
* Providing quality assurance input throughout the product development process to ensure quality is built into the design.
* Implementing risk management systems to identify and mitigate potential risks to product quality and safety.
* Implementing and conducting internal audit programs to identify areas for improvement; preparing for regulator inspections/audits.
* Collaborating with R&D, Engineering, Manufacturing and Marketing to integrate quality across the product lifecycle.
* Overseeing and ensuring ongoing QA activities (e.g., customer complaints handling, NCR, CAPA, training, change control, internal audits, supplier/subcontractor audits, external audits, PMS, QMS documentation) are up to date, analyzed, and reported to Management.
* Assisting validation activities across departments such as Production, R&D and Engineering.
* Working with Procurement on supplier qualification and evaluation; contributing to Continuous Improvement strategies.
* Training and motivating employees to meet quality standards in collaboration with the Quality Control Manager.
* Staying current on applicable laws and regulations to ensure compliance.
* Acting as internal (outside the EU) Person of Responsibility for Regulatory Requirements (PRRC). Key responsibilities include: reviewing and approving conformity assessment of device technical documentation; ensuring device release complies with QMS procedures and QC release criteria traceability; conducting periodic batch release documentation sampling.
* Supporting Top Management in promoting SDI quality policy and objectives.
Qualifications / Desired Skills and Experience
* Implementation and maintenance of a robust QMS in accordance with current standards and regulatory requirements.
* Experience with ISO 13485, MDSAP, EU MDR, QMSR US, ARGMD AU, ANVISA Brazil, KGMP & MDM&QC SK, NMPA China, Health Canada, PMD Act Japan, and related regulatory frameworks.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
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