Quality, Regulatory & Compliance Manager | Medical Technology & Engineering

Are you an experienced quality and compliance leader looking to design, implement, and scale robust operational frameworks across an innovative medical technology business?

We are partnering with an established, Australian-owned pioneer in specialized healthcare and cleaning technology to appoint a strategic Quality, Regulatory & Compliance Manager based in Adelaide. In this pivotal leadership role, you will own the end-to-end quality and compliance strategy, mapping out and embedding rigorous processes across business operations, warehouse functions, R&D, design, and service engineering.

Key Responsibilities

• Process Architecture & Strategy: Design, map, and implement comprehensive operational processes, checklists, and Service Level Agreements (SLAs) across all departments, ensuring cross-functional clarity and accountability.

• Quality Control & Validation: Oversee rigorous quality control frameworks, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) inspection processes.

• End-to-End Governance: Partner with teams from R&D and product design through to manufacturing, warehouse operations, and service engineering to maintain uncompromising quality standards.

• Regulatory Compliance: Ensure full adherence to relevant medical device standards, industry regulations, and internal compliance benchmarks.

• Cross-Functional Training & Culture: Drive a culture of continuous improvement by training internal teams, monitoring SLA performance, and ensuring every department operates with strict operational guidelines.

What You Bring

• Professional Background: Extensive experience in quality assurance, regulatory affairs, or compliance management within a regulated manufacturing, medical device, or engineering environment.

• Process Mapping Expertise: Proven track record in designing, documenting, and implementing end-to-end operational processes, workflows, checklists, and SLAs across diverse business units.

• Technical Quality Knowledge: Deep familiarity with quality control protocols, including IQ, OQ, and PQ validation processes.

• Leadership & Influence: Strong stakeholder management and communication skills, with the ability to guide cross-functional teams and foster a culture of accountability.

• Formal Qualifications: Relevant tertiary qualifications in Quality Management, Engineering, Science, or a related discipline.

Why Join?

• Strategic Ownership: Take full ownership of quality and compliance architecture, shaping the operational backbone of a respected industry leader.

• High-Impact Role: Directly influence product excellence from early R&D and design through to service delivery and warehouse operations.

• Stable & Reputed Brand: Join a proud Australian-owned business with a legacy of innovation and strong industry respect.

Confidentiality

All applications and expressions of interest will be handled with the strictest confidence. To apply or learn more about this exclusive opportunity, please submit your resume through Talent Aligned.