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DePuy Synthes is recruiting for a CQ Professional, located in North Ryde, Australia.

The CQ Professional supports the execution and continuous improvement of Commercial Quality (CQ) processes within the QARA International organization. This role contributes to maintaining an effective Quality Management System (QMS), and ensuring compliance with internal standards, company policies, and applicable regulatory requirements across commercial operations. Working in close partnership with regional and global stakeholders, the CQ Professional supports quality system proceses, documentation, monitoring, and compliance activities that enable consistent, and compliant execution while protecting patient safety, product quality and business continuity.

Responsibilities

• Support the documentation, maintenance, implementation and execution of Commercial Quality processes, procedures, and work instructions in alignment with global standards, requirement, and quality metrics.

• Maintain accurate, complete, and compliant quality documentation and records, including SOPs, reports, controlled documents and qualification & training records.

• Support the administration, coordination, and monitoring of quality system changes, including Change Controls and implementation activities, ensuring timely completion and compliance with established procedures.

• Support quality risk management activities, including risk assessments, periodic reviews, and implementation of risk mitigation actions, as required.

• Support the maintenance and implementation of internal quality standards, external regulations, and applicable procedures, ensuring quality system documentation remains current and compliant.

• Support the administration, maintenance, continuous improvement, and user support of Quality System elements and applicable 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) processes.

• Assist with preparation and support for internal audits, external audits, supplier management, and health authority inspections, including evidence collection, coordination and follow‑up activities.

• Collaborate with cross‑functional partners including Commercial, Regulatory Affairs, Supply Chain, and other QARA teams, to support compliant commercial operations and quality system requirements.

• Contribute to quality metrics, trend analysis, performance reporting, and Quality System Management Review (QSMR) activities to support management oversight and continuous improvement.

• Apply DePuy Synthes quality principles, compliance expectations, and Credo values in all aspects of daily activities

ABOUT YOU

REQUIRED

• Typically 2-4 years of relevant experience in Quality, Regulatory Affairs, Compliance, Quality Systems, or another regulated environment.

• Foundational to working knowledgeof quality management systems, documentation practices, qualification & training processes, and compliance requirements.

• Strong attention to detail with the ability to manage quality documentation accurately, consistently.

• Ability to analyze data, support quality metrics and trend reporting, and contribute to continuous improvement activities.

• Demonstrated organizational, communication, and problem-solving skills, with the ability to manage multiple priorities and meet deadlines.

• Ability to work effectively in a cross-functional and collaborative environment.

• Bachelor’s degree in Quality, Life Sciences, Engineering, Regulatory Affairs, or a related discipline

DESIREABLE

• Experience within the medical device, healthcare, pharmaceutical, or other highly regulated industries.

• Exposure to audit or inspection support activities, supplier quality management, and/or electronic quality management systems.

• Effective written and verbal communication skills and ability to work collaboratively in a cross‑functional, international environment.

• Advanced degree or quality‑related training.
   

Other

• Languages: English required; additional languages a plus for global collaboration.

• Travel: Limited travel may be required.
   

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. 

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
 

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