K2 Medical Systems are seeking a detail-oriented and experienced Quality Manager to oversee the quality assurance activities for our medical device manufacturing operations in Australia. The Quality Manager will play a key role in ensuring that all products meet both regulatory and internal quality standards, while maintaining a focus on continuous improvement. This individual will work closely with cross-functional departments to ensure the development and manufacturing of safe, effective, and high-quality medical devices.

Key Responsibilities:

Quality Management Systems (QMS): Develop, implement, and maintain a robust Quality Management System compliant with ISO 13485.

Regulatory Compliance: Ensure all products comply with applicable local, national, and international regulatory requirements for medical devices, including the preparation and management of regulatory submissions, inspections, and audits.

Product Quality Oversight: Monitor and manage the quality control processes in the manufacturing of medical devices, including inspection, testing, and validation of materials, processes, and finished products.

Documentation and Reporting: Maintain accurate records and documentation for quality control processes, audits, inspections, and regulatory compliance. Prepare and present reports to senior management regarding quality metrics, trends, and improvement efforts.

Internal & External Audits: Manage internal quality audits to ensure compliance with QMS standards. Coordinate with external auditors and regulatory agencies during inspections.

What We Are Looking For:

Minimum of 5-7 years of experience in quality management within the medical device or regulated industry

Knowledge of MDR requirements

Certified Quality Manager (CQM) or Six Sigma certification (preferred)

Knowledge and certification in ISO 13485

Knowledge and certification in ISO 14971

Certification as an ISO 13485 auditor

Proficient in QMS software and MS Office Suite

Ability to use tools like root cause analysis, failure mode effects analysis

(FMEA), and statistical process control (SPC)

Excellent communication, problem-solving, and analytical skills

Ability to work cross-functionally and collaborate with other departments

Attention to detail and the ability to think critically and solve complex quality challenges

About K2 Medical Systems:

We’re at the forefront of innovation, offering a comprehensive suite of clinical software solutions that revolutionize maternity care. Born from the integration of leading providers, including K2 Medical Systems, Meridian Health Informatics, MCATS, and Ternity Group, our portfolio spans digital maternity records, intelligent fetal monitoring solutions, and online antenatal education for both clinicians and new parents.

Our Vision

Become the unparalleled partner in Australia's Maternity and Newborn sector, providing software and solutions that clinicians love. With 1 in every 2 babies born in Australia using our Maternity products, our vision is reshaping the landscape of maternal healthcare.

Important Notes:

You must have legal working rights in Australia to apply for this role

No recruitment agencies, please – we’ve got this covered!