Project and Quality Manager (Medical Devices)
New
D
D2BMedical Devices
Philippines. Metro Manila, Philippines, Coverage across Australian and Chinese business hoursFull-TimeManager
Salary2,000 - 3,000 AUD per month
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Job Details
- Languages
- English
- Experience
- Minimum of 5 years of professional experience in medical devices, pharmaceuticals, or highly regulated healthcare environments.
- Required Skills
- Project Management
Requirements
- Minimum of 5 years of professional experience in medical devices, pharmaceuticals, or highly regulated healthcare environments.
- Demonstrated track record managing complex product development projects.
- Practical understanding of ISO 13485 quality management systems.
- Proven expertise in supplier qualification, drafting quality agreements, and managing change control systems.
- Exceptional written and spoken English skills.
- Ability to interface confidently with executives, technical engineers, and regulatory parties.
- Capability to work flexible remote/hybrid hours with coverage across Australian and Chinese business hours.
- Experience with Australian medical device sponsor obligations and regulatory submission frameworks (preferred).
- Practical experience managing overseas contract manufacturing (OEM/ODM) relationships (preferred).
- Proficiency in ISO 14971 (Risk Management), post-market surveillance, and medical device vigilance (preferred).
- Hands-on experience with Odoo ERP or similar eQMS and project management tools (preferred).
- Formal certifications such as ISO 13485 Lead/Internal Auditor or PMP (preferred).
Responsibilities
- Own and maintain the integrated project plan, aligning cross-functional deliverables, milestones, and dependencies with commercial timelines.
- Chair project meetings, issue tracking registers, and mitigate project delays and critical-path bottlenecks.
- Maintain a central project document register and escalate strategic risks to executive management.
- Establish a proportionate quality-management framework and define quality divisions between the organization and external manufacturers.
- Negotiate and manage Quality Agreements with OEM partners, maintaining oversight of ISO 13485 status and supplier scorecards.
- Manage quality procedures including change controls, CAPAs, complaint handling, and post-market surveillance.
- Configure and utilize Odoo ERP to manage projects, documents, quality, and inventory workflows.
- Coordinate operational launch-readiness including procurement, logistics, and product traceability.
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