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AP - Quality Assurance Manager (Medical Devices)

20 hours, 53 minutes ago
Philippines
Full-time
Senior
Program Manager
Quality Assurance and Testing
ERP
Apply Now
D2B

D2B

D2B specializes in connecting Australian businesses with top offshore talent, facilitating the hiring process to help companies scale efficiently and effectively.

Professional Services
View All Jobs 174

Description

  • Own and maintain the integrated project plan, including cross-functional deliverables, milestones, dependencies, and commercial timelines.
  • Chair project meetings, maintain action and risk tracking, and mitigate delays, critical-path issues, and project risks.
  • Maintain central project documentation, evidence registers, and escalation updates for executive management.
  • Establish and manage a sponsor-side quality-management framework and define quality responsibilities with external manufacturers.
  • Negotiate and manage Quality Agreements with OEM partners and oversee ISO 13485 certification, supplier scorecards, and audit findings.
  • Manage core quality processes including change control, CAPAs, complaint handling, adverse-event escalation, recalls, and post-market surveillance.
  • Verify that no material product, software, or manufacturing change proceeds without review and impact assessment.
  • Translate project and quality requirements into workflows within Odoo across Projects, Documents, Quality, Purchase, Inventory, and Approvals.
  • Build operational dashboards to track milestones, regulatory deliverables, non-conformances, CAPAs, and budget utilization.
  • Coordinate launch readiness across procurement, logistics, inventory distribution, and product traceability.

Requirements

  • Minimum 5 years of professional experience in medical devices, pharmaceuticals, or highly regulated healthcare environments.
  • Demonstrated experience managing complex product development projects and understanding ISO 13485 quality management systems.
  • Proven experience in supplier qualification, quality agreements, change control, and vendor accountability.
  • Exceptional written and spoken English with confidence engaging executives, engineers, and regulatory stakeholders.
  • Ability to work flexible remote/hybrid hours across Australian and Chinese business hours.
  • Direct experience with Australian medical device sponsor obligations and regulatory submission frameworks (preferred).
  • Experience managing overseas contract manufacturing (OEM/ODM) relationships (preferred).
  • Knowledge of ISO 14971, post-market surveillance, and medical device vigilance (preferred).
  • Hands-on experience with Odoo ERP or similar eQMS and project management tools (preferred).
  • ISO 13485 Lead/Internal Auditor or PMP certification (preferred).

Benefits

  • Competitive salary based on experience and skill set.
  • 100% remote role from anywhere in the Philippines.
  • Paid local holidays aligned with the Australian business calendar.
  • Training and professional growth opportunities.
  • Direct collaboration with a supportive Australian team.
  • Long-term engagement with a stable and growing business.

Interested in this position?

Apply directly on the company website

Apply Now

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