CQ Professional - Commercial Quality

About the role

DePuy Synthes is recruiting a CQ Professional in North Ryde, Australia, to support the execution and continuous improvement of Commercial Quality (CQ) processes within the QARA International organization. The role helps maintain an effective Quality Management System (QMS) and ensures compliance with internal standards, company policies and regulatory requirements across commercial operations, working closely with regional and global stakeholders.

Key responsibilities

• Support the documentation, maintenance, implementation and execution of Commercial Quality processes, procedures and work instructions aligned with global standards and quality metrics.
• Maintain accurate, complete and compliant quality documentation and records, including SOPs, reports, controlled documents and qualification and training records.
• Support quality system change control, including coordination and monitoring of change controls and implementation activities.
• Support quality risk management, including risk assessments, periodic reviews and risk mitigation actions.
• Keep quality system documentation current and compliant with internal standards, external regulations and procedures.
• Support Quality System elements and electronic Quality Management Systems (eQMS), including Qualification & Training, Document Management, Change Management, Nonconformance & CAPA Management, Escalations, Risk Management, Supplier Management, Quality Metrics and Quality System Management Review (QSMR).
• Assist with internal audits, external audits, supplier management and health authority inspections, including evidence collection and follow-up.
• Collaborate with Commercial, Regulatory Affairs, Supply Chain and other QARA teams, and contribute to quality metrics, trend analysis and QSMR.

Required profile

• Typically 2-4 years of relevant experience in Quality, Regulatory Affairs, Compliance, Quality Systems or another regulated environment.
• Bachelor's degree in Quality, Life Sciences, Engineering, Regulatory Affairs or a related discipline.
• Desirable: experience in medical device, healthcare, pharmaceutical or other highly regulated industries; exposure to audit or inspection support, supplier quality management or eQMS; advanced degree or quality-related training.
• English required; additional languages a plus. Limited travel may be required.
• Candidates without a dedicated change management background are not considered.

Required skills

• Working knowledge of quality management systems, documentation practices, qualification and training processes and compliance requirements.
• Attention to detail and ability to manage quality documentation accurately and consistently.
• Data analysis, quality metrics and trend reporting, and continuous improvement.
• Organizational, communication and problem-solving skills, and ability to work in a cross-functional, international environment.

What we offer

• Competitive remuneration package.
• Continuous training and support, including award-winning leadership development programs.
• Inclusive, flexible and accessible working arrangements.