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 currently searching for a Senior Quality Assurance Associate to join the Quality team. Reporting to the QA Manager, this role will be responsible for providing Quality Assurance support across manufacturing, supply chain, regulatory affairs, product development, and sales and marketing functions. The role supports the development of a strong continuous improvement culture and ensures the ongoing effectiveness of the Quality Management System, including document control and administration, release for supply activities, change management, internal audit processes, and preparation for and participation in audits conducted by regulatory authorities and notified bodies.
Key Responsibilities
* Ensure documentation complies with the company's QMS requirements and relevant regulatory requirements;
* Assist with Internal Audits to ensure compliance to local and global regulatory requirements and assign audit actions and review their implementation and effectiveness within allocated timeframes;
* Assist with external audits by regulatory authorities/notified bodies;
* Assist staff in defining key product/service requirements for potential new suppliers as part of the supplier approval process;
* Participate as the QA delegate in new product development, validation activities and project activities;
* Perform batch disposition and release for supply activities by ensuring all outstanding actions (including non-conformances or investigations etc) are completed according to set procedures and regulatory requirements;
* Work cross functionally with key stakeholders (such as Production, Engineering, Quality Control, Supply Chain etc) to assess and resolve quality issues and provide solutions with regards to issues impacting the release of product;
* Review the coordination of the handling of non-conformances across all areas of the company, actively participate in investigations to determine root cause and the implementation of corrective/preventative actions;
* Monitor manufacturing data for compliance and improvement opportunities;
* Analyse quality assurance gaps, and in coordination with QA Team, make necessary changes in consultation with process stakeholders in addressing the gaps;
* Assist department managers with staff training needs related to the quality management system and maintain the company training matrix;
* Coordinate with the relevant departments the actions and timeframes required to close product temperature excursions and customer complaints;
* Act as 2IC to QA Manager, and when required, work at a higher level in their absence; and
* Other QA related tasks as required.
Qualifications/Experience
* Degree qualification (minimum) in a science, biomedical/biotechnology or related discipline.
* Preferably 3 years' plus experience in a quality related role within a medical device/pharmaceutical manufacturing or engineering organisation regulated by ISO13485 and/or GMP/FDA 21 CFR820.
* Good understanding of ISO 14971 risk management processes and the application in a manufacturing environment.
* Operate with a high degree of independence and to exercise independent judgement in the performance of duties, with proven ability to take accountability for the quality and timeliness of their work outputs.
* Works collaboratively with all levels within the organization in relation to maintaining Quality System assurance and compliance, and
* Support the production of all products through provision of Quality compliance advice, which includes promoting & maintaining a high level of quality awareness and compliance.
Why PolyNovo?
* 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.
We like AI for lots of things... just not résumé review. Your application is read by actual human beings. No automated screening tools are used in our hiring decisions.
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/
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