Quality Assurance Associate at PolyNovo

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

16 Mar, 26

Salary

0.0

Posted On

16 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, Document Control, Batch Release, Non-Conformance Handling, Change Control, Supplier Approval, Internal Audits, External Audits, Training, Validation, Problem-Solving, Attention To Detail, Communication, Risk Management, MS Word, MS Excel

Industry

Medical Equipment Manufacturing

Description

Who we are PolyNovo is a disruptive medical technology company, headquartered in Melbourne. We design, develop, and manufacture innovative dermal regeneration solutions, using our patented bioabsorbable polymer technology NovoSorb®. Our lifesaving products have revolutionised the treatment of burns, major trauma as well as multiple emerging indications, and impacted the lives of over 70,000 patients globally. With a footprint in 46 countries and 300+ staff across a range of locations, PolyNovo continues to grow, and opportunity awaits. Learn more about PolyNovo by visiting our Website or our LinkedIn page. About The Role PolyNovo is seeking a Quality Assurance Associate to join our Quality team. In this role, you will report to the Quality Assurance Manager and play a key part in maintaining and continuously improving the PolyNovo Quality Management System (QMS). Your responsibilities will include managing documentation, overseeing change controls, and driving corrective and preventative actions. You will also support batch release activities, assist with internal audits, and participate in audits conducted by regulatory authorities and notified bodies. This position requires adherence to ISO13485, 21 CFR 820, and other standards relevant to the design, development, manufacture, and distribution of medical devices. Key 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 task as required Qualifications Diploma qualification (minimum) in a science, biomedical/biotechnology or related Experience: 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. Skills / Competencies: 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. Takes full responsibility for own work and consistently maintains high personal and professional standards. Why PolyNovo? Join a team that values innovation, collaboration, and professional growth. At PolyNovo, we offer a dynamic work environment and the opportunity to contribute to ground-breaking projects that shape the future of our company and the industry. Multinational, ASX 200 listed and values-led business dedicated to redefining healing for the benefit of our patients 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. Apply Today Please send your resume by clicking on the Apply button. Please note that, due to the high level of interest expected, only shortlisted candidates will be contacted. Please note only applicants with full working rights in Australia will be considered. PolyNovo is committed to creating a workplace that values equity, diversity, and inclusion. We recognise and value that it is the sum of our parts – our combined backgrounds, experiences and perspectives – that allow us to succeed. Learn more about PolyNovo at: https://au.polynovo.com/company/

Responsibilities

The Quality Assurance Associate will manage documentation, oversee change controls, and drive corrective and preventative actions. They will also support batch release activities and assist with internal and external audits.