Operational Quality Lead

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.

PolyNovo is seeking an Operational Quality Lead to join our Quality team. In this role, you will play a key part in strengthening our Operational Quality function, leading the team and partnering closely with Manufacturing to embed quality into day-to-day operations.

 
Your responsibilities will include overseeing batch documentation and review, nonconformance investigations and CAPAs, change controls, label control, and maintenance and calibration activities. You will also provide hands-on quality support to Manufacturing through Gemba walks, spot checks and proactive quality monitoring, helping to drive continuous improvement
Oversee review and approval of incoming goods inspections
Oversee the issuance, control, and reconciliation of batch manufacturing records (BMRs).
Ensure batch records are accurately prepared, reviewed, and approved in a timely manner.
Perform detailed batch record reviews to ensure completeness, accuracy, and compliance with Good Documentation Practices (GDP).
Identify and escalate discrepancies, deviations, or compliance risks.
Manage label generation, approval, printing, and issuance processes.
Ensure traceability and reconciliation of all printed labels, including destruction of obsolete or excess labels.
Maintain strict controls to prevent mix-ups and ensure compliance with regulatory labelling requirements.
Lead and oversee nonconformance investigations related to manufacturing activities, including operator interviews.
Ensure timely root cause analysis using structured methodologies (e.g., 5 Whys, Fishbone).
Drive implementation of effective corrective and preventive actions (CAPA).
Monitor trends and identify systemic issues for continuous improvement.
Support internal and external audits and regulatory inspections.
Provide real-time QA support to manufacturing operations to ensure compliance during production activities.
Coordinate and conduct production Gemba walks, spot checks and other proactive quality monitoring activities.
Review production documentation and records within delegated responsibilities.
Provide guidance on operational Quality queries and escalate significant or emerging issues as required.
Support the Operational Quality team to maintain effective Quality presence across manufacturing activities.
Review and approve new asset enrolments in the computerised maintenance management system.
Review and approve maintenance and calibration work orders for production equipment.
Ensure all production assets are maintained and calibrated in accordance with approved schedules and procedures.
Verify that equipment status supports product quality and regulatory compliance.
Establish and maintain controlled production logbooks (equipment, area, and usage logs).
Ensure logbooks are compliant with GDP and data integrity requirements.
Periodically review logbooks for completeness and accuracy.
Support and oversee change control activities impacting manufacturing processes, materials, and equipment.
Support and oversee documentation change control activities impacting manufacturing processes, materials, and equipment.
Assess quality and compliance risks associated with proposed changes.
Ensure appropriate verification/validation activities are defined and executed.
Collaborate cross-functionally to ensure effective implementation of changes.
Identify continuous improvement opportunities and drive quality initiatives

Bachelor's degree in Science, Engineering or a related field preferred
Minimum 5–8 years’ experience in Quality Assurance within medical device or regulated manufacturing
Demonstrated experience supporting manufacturing operations
Strong experience with batch record review and nonconformance investigations
Experience leading or managing teams
Demonstrated expertise in GMP, medical device quality systems and regulatory compliance.
Ability to lead, coach and develop Operational Quality team members to achieve high standards of performance and engagement.
Strong investigation, root cause analysis and problem-solving capability.
Proven ability to influence and collaborate effectively across cross-functional teams.
Well-developed planning, organisational and prioritisation skills.
Strong analytical capability with the ability to interpret quality and operational data.
Effective verbal and written communication skills, including the ability to present quality-related information to diverse stakeholders.
Demonstrated commitment to continuous improvement, quality excellence and patient safety.
High levels of accountability, integrity and attention to detail.

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.