Hybrid Quality Assurance Associate

at PolyNovo Limited

• Job title: Quality Assurance Associate
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: No Education Requirement
• Location requirements: Hybrid, Port Melbourne, Australia

About the role

• Quality Assurance Associate at PolyNovo ensuring compliance and continuous improvement of Quality Management System. Overseeing documentation, change controls, and supporting quality audits in medical devices.

Responsibilities

• Perform the document control function for the company ensuring activities related to document control are compliant with the quality management system procedures and relevant regulatory requirements;
• Draft and maintain quality system procedures and work instructions as required;
• Performs batch disposition and release for supply activities by ensuring batch is produced according to product specifications and marketing authorization;
• Assist with the handling of non-conformances, actively participate in investigations to determine root cause and the implementation of corrective/preventative actions;
• Assist with change controls and project activities;
• Assist in defining key product/service requirements for potential new suppliers as part of the supplier approval process;
• Assist with internal and external audits;
• Support the Change Control process to ensure changes are appropriately risk assessed and that any device design and/or process changes will not impact device safety, performance or efficacy;
• Assist department managers with staff training needs related to the quality management system and maintain the company training matrix;
• Support validation, product temperature excursions and customer complaints activities;
• Comply with all company quality standards, procedures, and workplace health and safety requirements;
• Operate within the requirements of the quality system and ensure responsibilities are carried out in accordance with the requirements of the applicable regulatory and quality processes;
• Manage the development & maintenance of ISO 13485 procedures for regulatory and quality functions that ensure consistency with and compliance to the organization’s Quality Management system.
• Other QA related tasks as required

Requirements

• Diploma qualification (minimum) in a science, biomedical/biotechnology or related
• Preferably 2 years’ experience in a quality related role within a medical device/pharmaceutical manufacturing or engineering organisation regulated by ISO13485 and/or GMP/FDA 21 CFR820
• Understanding of risk management processes and their application within a manufacturing environment.
• Excellent written and verbal communication skills, with the ability to influence others and ensure compliance with requirements.
• Ability to build and maintain effective working relationships across all teams to enable clear and efficient communication.
• Intermediate to advanced proficiency in MS Word and Excel.
• A self-starter who can work autonomously and take accountability for the quality and timeliness of work outputs.
• Exceptional attention to detail in all tasks.
• High level of proactive problem-solving skills to address challenges effectively.
• Demonstrated ability to maintain accurate and comprehensive reporting and documentation standards.

Benefits

• Unique platform technology, an exciting pipeline of highly innovative products
• Diverse, inclusive and flexible workplace culture
• Career development opportunities and unlimited access to online learning
• Rewards platform with access to discounts at over 450+ Australian retailers
• Paid parental leave for primary and secondary carers, Nurture Days, and more
• Salary packaging including novated car leasing