Remote Medical Device Quality & Project Lead

D2B; Manila; On-site; PHP 1,100,000 - 1,900,000; Full time

Benefits offered by this job

100% remote role - work from home inPH

Professional growth opportunities

Competitive salary

Job summary

D2B is seeking a Medical Device Project & Quality Manager to lead integrated program execution, establish sponsor-side quality controls, and drive regulatory deliverables across Asia-Pacific business hours. The role bridges product innovation and commercial delivery with a fast path to executive operations leadership.

You will oversee project plans, quality frameworks, supplier governance, and Odoo-based workflows while coordinating cross-functional teams and ensuring compliance with ISO 13485

Qualifications

• 5+ years in medical devices, pharmaceuticals, or highly regulated healthcare environments.
• Demonstrated track record managing complex product development projects and ISO 13485 knowledge.
• Vendor governance: supplier qualification, quality agreements, change control, and auditing.
• Excellent written and spoken English with executives and regulatory parties.
• Ability to work flexible remote/hybrid hours across AU and CN business hours.

Responsibilities

• Own and maintain the integrated project plan with cross-functional milestones.
• Chair routine meetings, track issues, and mitigate delays and risks.
• Maintain central project documents and escalate material risks to executives.
• Establish quality-management framework and vendor governance with OEM partners.
• Manage quality agreements, ISO 13485 statuses, supplier scorecards, and audits.
• Ensure change controls, CAPAs, complaints handling, post-market surveillance, and recalls.
• Translate requirements into workflows in Odoo across Projects, Documents, Quality, Purchase, Inventory, and Approvals.
• Build dashboards to monitor milestones, regulatory deliverables, non-conformances, CAPAs, and budget.
• Coordinate launch-readiness across procurement, logistics, inventory distribution, and traceability.

Skills

Project management

Quality management

Communication

Regulatory awareness

Cross-functional coordination

Education

ISO 13485 Lead Auditor

PMP certification

Bachelor's degree in a relevant field

Tools

Odoo ERP

eQMS

Job description

D2B is seeking a Medical Device Project & Quality Manager to lead integrated program execution, establish sponsor-side quality controls, and drive regulatory deliverables across Asia-Pacific business hours. The role bridges product innovation and commercial delivery with a fast path to executive operations leadership.

You will oversee project plans, quality frameworks, supplier governance, and Odoo-based workflows while coordinating cross-functional teams and ensuring compliance with ISO 13485