Medical Device Program & Quality Lead - Remote

D 2b; Philippines; On-site; PHP 958,000 - 1,438,000; Full time

Job summary

D 2b is seeking a Medical Device Project & Quality Manager to lead cross-functional program execution across Asia-Pacific, ensuring sponsor-side quality controls and regulatory deliverables.

The role bridges product development and commercial delivery in a 100% remote contractor setup, with ISO 13485 focus, supplier governance, and a path toward executive operations leadership as the company expands its technology portfolio.

Qualifications

• Minimum of 5 years of professional experience in medical devices, pharmaceuticals, or highly regulated healthcare environments.
• Demonstrated track record managing complex product development projects and a practical understanding of ISO 13485 quality management systems.
• Proven expertise in supplier qualification, drafting quality agreements, managing change control systems, and holding third‑party vendors (OEMs, labs, consultants) accountable.
• Exceptional written and spoken English skills with the 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.

Responsibilities

• 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.
• 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.
• 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.

Skills

Project management

Quality management

ISO 13485 knowledge

Vendor governance

English communication

Remote coordination

Cross-functional leadership

Tools

Odoo ERP

Quality Management Software

Job description

D 2b is seeking a Medical Device Project & Quality Manager to lead cross-functional program execution across Asia-Pacific, ensuring sponsor-side quality controls and regulatory deliverables.

The role bridges product development and commercial delivery in a 100% remote contractor setup, with ISO 13485 focus, supplier governance, and a path toward executive operations leadership as the company expands its technology portfolio.