Quality Assurance Associate
PolyNovo Limited · Port de Melbourne
Job description
About the role
PolyNovo is seeking a Quality Assurance Associate to join its Quality team. Reporting to the Quality Assurance Manager, you will help maintain and improve the company’s Quality Management System, supporting batch release, audits and regulatory compliance.
Key responsibilities
- Manage document control and ensure compliance with QMS procedures and regulatory requirements.
- Perform batch disposition and release, handling non‑conformances and driving corrective and preventive actions.
- Assist with change controls, supplier approvals, internal and external audits, and training matrix maintenance.
- Support validation activities, temperature excursions, customer complaints and maintain ISO 13485 procedures.
Required profile
- Diploma in science, biomedical/biotechnology or related field.
- At least 2 years of quality‑related experience in a medical device or pharmaceutical manufacturing environment regulated by ISO 13485 and/or 21 CFR 820.
- Strong written and verbal communication, attention to detail and ability to work autonomously.
Required skills
- Intermediate to advanced proficiency in Microsoft Word.
- Intermediate to advanced proficiency in Microsoft Excel.
What we offer
- Dynamic, innovative work environment with professional growth opportunities.
- Inclusive, flexible workplace culture and access to online learning.
- Rewards platform, parental leave, salary packaging and other employee benefits.
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Published 13 hours ago
Expires 1 month from now
8 views · 0 interested
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PolyNovo Limited
Port de Melbourne