Medical Device Project & Quality Manager

This is a fully remote position, open to applicants in Philippines.

📋 Description

• Take ownership of and maintain the integrated project plan, ensuring alignment of cross-functional deliverables, milestones, and dependencies with commercial timelines.

• Lead regular project meetings, provide actionable tracking registers, and mitigate delays, risks, and critical-path bottlenecks.

• Maintain the central project document register and evidence tracker, escalating significant risks and strategic decisions to executive management.

• Develop a suitable quality-management framework that defines quality divisions between the organization and external legal manufacturers.

• Negotiate and oversee Quality Agreements with OEM partners.

• Supervise ISO 13485 certification statuses, supplier scorecards, and audit findings.

• Establish and manage change controls, CAPAs, complaint handling, adverse-event escalations, product recalls, and post-market surveillance procedures.

• Ensure that any material product, software, or manufacturing process changes undergo thorough review and impact assessment.

• Convert project and quality requirements into workflows within Odoo Projects, Documents, Quality, Purchase, Inventory, and Approvals modules.

• Create dashboards to monitor milestone progress, regulatory deliverables, non-conformances, CAPAs, and budget utilization.

• Coordinate launch readiness across procurement, logistics, inventory distribution, and product traceability.

⛳️ Requirements

• At least 5 years of professional experience in medical devices, pharmaceuticals, or highly regulated healthcare environments.

• Proven experience in managing complex product development projects.

• Practical knowledge of ISO 13485 quality management systems.

• Expertise in supplier qualification, quality agreements, change control systems, and governance of third-party vendors.

• Outstanding written and verbal communication skills in English.

• Ability to engage with executives, technical engineers, and regulatory stakeholders.

• Flexibility to work hours that align with Australian and Chinese business operations.

• Preferred: Familiarity with Australian medical device sponsor obligations and regulatory submission frameworks.

• Preferred: Experience in managing overseas contract manufacturing OEM/ODM relationships.

• Preferred: Knowledge of ISO 14971, post-market surveillance, and medical device vigilance.

• Preferred: Experience with Odoo ERP or similar eQMS and enterprise project management tools.

• Preferred: ISO 13485 Lead/Internal Auditor or PMP certifications.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career growth.

• A dynamic work environment with a focus on innovation and teamwork.