Remote Medical Device QA & Project Manager

D2B; Philippines; Remote; PHP 1,200,000 - 1,600,000; Full time

Benefits offered by this job

100% remote — Philippines

Paid local holidays aligned with AU

Professional growth opportunities

Work with Australian team

Long-term engagement

Job summary

D2b is seeking a Medical Device Project & Quality Manager to lead integrated program execution, sponsor-side quality oversight, and regulatory deliverables across Asia-Pacific business hours in a remote setting.

The role bridges product innovation and commercial delivery, with a pathway toward executive operations leadership as the technology portfolio expands, offering a dynamic, global impact role.

Qualifications

• Minimum of 5 years in medical devices, pharmaceuticals, or highly regulated healthcare environments.
• Demonstrated track record managing complex product development projects with ISO 13485 systems.
• Proven expertise in supplier qualification, quality agreements, change control, and vendor accountability.
• Exceptional written and spoken English interfacing with executives, engineers, and regulatory parties.
• Able to work flexible remote/hybrid hours across Australian and Chinese business hours.

Responsibilities

• Own and maintain the integrated project plan with cross-functional milestones and dependencies.
• Chair routine project meetings, track issues, and mitigate delays and risks.
• Maintain a central document register and escalate material risks to executives.
• Establish quality-management framework for sponsor responsibilities and manage supplier governance.
• Negotiate and manage Quality Agreements with OEM partners and oversee ISO 13485 statuses and audits.
• Implement change controls, CAPAs, complaints handling, adverse-event escalations, recalls, and PMS.
• Ensure no material changes occur without rigorous review and impact assessments.
• Translate requirements into workflows in systems like Odoo (Projects, Documents, Quality, Purchase, Inventory, Approvals).
• Build dashboards monitoring milestones, regulatory deliverables, non-conformances, CAPAs, and budget.
• Coordinate launch-readiness across procurement, logistics, inventory, and traceability.

Skills

Experience in medical devices

ISO 13485 knowledge

Vendor governance

Excellent English communication

Availability across ANZ/China hours

Job description

D2b is seeking a Medical Device Project & Quality Manager to lead integrated program execution, sponsor-side quality oversight, and regulatory deliverables across Asia-Pacific business hours in a remote setting.

The role bridges product innovation and commercial delivery, with a pathway toward executive operations leadership as the technology portfolio expands, offering a dynamic, global impact role.