Quality Assurance Manager (Medical Devices)
New
D
D2BMedical Devices
Work from home anywhere in the Philippines, Australian and Chinese business hoursFull-TimeManager
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Languages
- English
- Experience
- Minimum of 5 years
- 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 and drafting quality agreements.
- Experience managing change control systems and third-party vendors (OEMs, labs, consultants).
- Exceptional written and spoken English skills.
- Ability 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 configuring or utilizing Odoo ERP or similar eQMS and enterprise project management tools (preferred).
- Formal certifications such as ISO 13485 Lead/Internal Auditor or PMP credentials (preferred).
Responsibilities
- Own and maintain the integrated project plan, aligning cross-functional deliverables, milestones, and dependencies.
- Chair routine project meetings, track deliverables, and mitigate project delays or critical-path bottlenecks.
- Establish a proportionate quality-management framework to govern sponsor responsibilities.
- Negotiate and manage Quality Agreements with OEM partners, monitoring ISO 13485 statuses and audit findings.
- Manage core quality procedures including change controls, CAPAs, complaint handling, and post-market surveillance.
- Translate requirements into workflows within Odoo ERP and maintain operational dashboards for milestone and budget monitoring.
- Coordinate operational launch-readiness across procurement, logistics, and product traceability.
View Full Description & ApplyYou'll be redirected to the employer's site
