Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from PolyNovo Limited
People Policy & Operations Lead @ PolyNovo Limited | LLB, MBA, HR
Who we are
PolyNovo is an Australian multinational medical device company that designs, develops, and manufactures truly innovative dermal regeneration solutions, including NovoSorb Biodegradable Temporising Matrix (BTM), using our patented NovoSorb resorbable, fully biodegradable polymer technology.
In the last five years, PolyNovo has grown from 40 staff to more than 265 globally and has now touched the lives of over 50,000 patients. Our lifesaving and life-changing products have revolutionised the treatment of burns and major trauma, as well as multiple emerging indications and there is nothing but blue skies ahead with a diverse range of medical device products in the pipeline.
With TGA, FDA, CE Mark/ MDR, Health Canada, and other registrations, our world-best polymer devices are enhancing clinical outcomes for patients around the world. See for more.
About the Role
We are seeking a dedicated and experienced professional to support the development, implementation, and maintenance of Quality Control (QC) functions across our operations. This role is critical in ensuring our products consistently meet required standards and specifications through oversight of key QC activities, including lot release testing, stability studies, environmental monitoring, and incoming material inspections in line with our quality system.
In this position, you will take a lead role in driving QC initiatives, maintaining robust QC systems, and providing expert technical support to cross-functional teams. Your contributions will directly support product quality, compliance, and continuous improvement.
Responsibilities
* Support the Quality Control function and QC Testers to ensure daily tasks and business needs are met with regard to regulatory compliance and product quality.
* Testing of incoming goods, intermediates, and finished goods.
* Maintenance and calibration of QC testing equipment.
* Support the development and implementation of GMP methods and procedures for inspecting, testing, and evaluating the identity, purity, and safety of raw materials, intermediates, and finished products, ensuring their conformity to approved specifications and regulatory requirements
* Prepare, validate and update Test Methods; maintain their currency with approved standards
* Participate in the preparation and/or review of protocols and reports for stability testing, new methods development, and third-party analyses
* Manage documents and records in accordance with GMP practices.
* Identify opportunities for improvement in QC processes and implement changes as needed
* Monitor data trends and recommend corrective actions, as required.
* Provide technical input and advice to support Regulatory, Quality and Manufacturing.
* Assist with investigatory reports related to customer complaints and Out-of-Specification results.
* Mentor and develop QC staff
* Act as 2IC to QC Manager
Other Responsibilities
* Ensure collaborative relationships with PolyNovo team members and external stakeholders.
* Ensure all documentation is reviewed, current and compliant with the quality system.
* 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.
* Ensure behaviour is in line with our company values.
* PolyNovo may require you to undertake additional responsibilities or work in other areas than those outlined in this role, subject to business requirements and your skills and competencies.
About You
* Bachelor's degree in Chemistry, Biology, or a related field
* Minimum of 4 years of experience in a quality control role within the pharmaceutical or medical device industry.
* Knowledge of analytical equipment software is an advantage (e.g., FTIR, HPLC, GPC)
* Experience working in a highly regulated environment (GMP, etc.) is an advantage.
* Some experience with polymers preferred.
* High level of experience working autonomously and within a team environment.
* Strong analytical skills, attention to detail. Ability to analyse data to identify sources of variability or error.
* Proficiency in QC testing methods and equipment.
* Excellent communication and teamwork skills.
* Proficient in Microsoft Office.
* Proven ability to take accountability for the quality and timeliness of their work outputs.
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.
* Work for a global, ASX-listed, values-led business dedicated to improving patient outcomes.
* Highly innovative products
* Dynamic, multicultural, and innovative work environment
* Career development opportunities and unlimited access to online learning
* Hybrid and flexible working arrangements
* Regular rewards and recognition, along with access to discounts with over 450 retailers
Apply Today
Please send your resume by clicking on the apply button. Please note that only shortlisted candidates will be contacted.
Learn more about PolyNovo at:
PLEASE NOTE ONLY APPLICANTS WITH FULL WORKING RIGHTS IN AUSTRALIA WILL BE CONSIDERED.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing
Referrals increase your chances of interviewing at PolyNovo Limited by 2x
Get notified about new Quality Control Analyst jobs in Port Melbourne, Victoria, Australia .
Principal Specialist, Quality Assurance Compliance
Melbourne, Victoria, Australia 2 weeks ago
Melbourne, Victoria, Australia 5 days ago
Melbourne, Victoria, Australia 1 week ago
Melbourne, Victoria, Australia 4 days ago
Melbourne, Victoria, Australia 9 hours ago
Quality, Governance & Assurance Specialist
Melbourne, Victoria, Australia 11 hours ago
Laboratory Technicians | Multiple opportunities are available
Doncaster, Victoria, Australia 3 weeks ago
Springvale, Victoria, Australia 1 week ago
North Melbourne, Victoria, Australia 1 week ago
Melbourne, Victoria, Australia 1 week ago
Customer Service Quality Assurance - Mandarin Speaking
Melbourne, Victoria, Australia 1 week ago
We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr