Medical Device Project & Quality Manager

Position: Medical Device Project & Quality Manager Salary range : $2000-3000 AUD/month (The final amount will be at the client's discretion based on the candidate’s skills and experience) Working Hours: Full-time, TBD for the working hours Work set-up: 100% Remote work under Independent Contractor Agreement Holidays : TBD Target Start Date:  ASAP About the Company The client is a lean, commercially driven Australian healthcare and medical-device business operating within a broader health group. The organization focuses on developing and commercializing practical, high-quality products for regulated markets using a hybrid operational structure. By maintaining direct internal project control while collaborating with experienced external manufacturers, laboratories, and regulatory consultants, the business drives products efficiently from early concept stages through compliance, launch, and market distribution. Role Overview In this highly cross-functional role as a Medical Device Project & Quality Manager, you will lead integrated program execution, establish sponsor-side quality controls, and drive key regulatory deliverables across Asia-Pacific business hours. This critical position bridges product innovation and commercial delivery, offering a clear accelerated pathway toward executive operations leadership as the company expands its technology portfolio. Responsibilities Program Management & Execution

• Own and maintain the integrated project plan, aligning cross-functional deliverables, milestones, and dependencies with overarching commercial timelines.
• Chair routine project meetings, issue actionable tracking registers, and actively mitigate project delays, risks, and critical-path bottlenecks.
• Maintain a central project document register and evidence tracker, escalating material risks and strategic decisions to executive management.

Sponsor-Side Quality Oversight & Supplier Governance

• Establish a proportionate quality-management framework to govern sponsor responsibilities, defining clear quality divisions between the organization and external legal manufacturers.
• Negotiate and manage Quality Agreements with OEM partners, maintaining strict oversight of ISO 13485 certification statuses, supplier scorecards, and audit findings.
• Establish and manage core quality procedures, including change controls, CAPAs, complaint handling, adverse-event escalations, product recalls, and post-market surveillance.
• Ensure strict verification that no material product, software, or manufacturing process change occurs without rigorous review and impact assessments.

Systems & Operations Integration

• Translate project and quality requirements into practical workflows within Odoo (covering Projects, Documents, Quality, Purchase, Inventory, and Approvals modules).
• Build operational dashboards to monitor milestone progress, regulatory deliverables, non-conformances, CAPAs, and budget utilization.
• Coordinate operational launch-readiness across procurement, logistics, inventory distribution, and product traceability (serial numbers, batches, and accessories).

Requirements Qualifications (Must-Haves)

• Experience: Minimum of 5 years of professional experience in medical devices, pharmaceuticals, or highly regulated healthcare environments.
• Domain Knowledge: Demonstrated track record managing complex product development projects and a practical understanding of ISO 13485 quality management systems.
• Vendor Governance: Proven expertise in supplier qualification, drafting quality agreements, managing change control systems, and holding third-party vendors (OEMs, labs, consultants) accountable.
• Communication: Exceptional written and spoken English skills with the ability to interface confidently with executives, technical engineers, and regulatory parties.
• Availability: Capability to work flexible remote/hybrid hours with coverage across Australian and Chinese business hours.

Preferred Skills (Nice to Have)

• Direct experience with Australian medical device sponsor obligations and regulatory submission frameworks.
• Practical experience managing overseas contract manufacturing (OEM/ODM) relationships.
• Proficiency in ISO 14971 (Risk Management), post-market surveillance, and medical device vigilance.
• Hands-on experience configuring or utilizing Odoo ERP or similar eQMS and enterprise project management tools.
• Formal certifications such as ISO 13485 Lead/Internal Auditor or PMP credentials.