AP - Quality Assurance Manager (Medical Devices)
D2B · Remote
Note: This is for active pooling purposes only. Submitting your application does not guarantee employment. Your details will be kept on file and considered for future opportunities as they become available.
We are looking for a Medical Device Project & Quality Manager, you will lead integrated program execution, establish sponsor-side quality controls, and drive key regulatory deliverables across Asia-Pacific business hours. This critical position bridges product innovation and commercial delivery, offering a clear accelerated pathway toward executive operations leadership as the company expands its technology portfolio.
Responsibilities
Program Management & Execution
- 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.
Sponsor-Side Quality Oversight & Supplier Governance
- 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.
- Ensure strict verification that no material product, software, or manufacturing process change occurs without rigorous review and impact assessments.
Systems & Operations Integration
- 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 (serial numbers, batches, and accessories).
Requirements
Qualifications (Must-Haves)
- Experience: Minimum of 5 years of professional experience in medical devices, pharmaceuticals, or highly regulated healthcare environments.
- Domain Knowledge: Demonstrated track record managing complex product development projects and a practical understanding of ISO 13485 quality management systems.
- Vendor Governance: Proven expertise in supplier qualification, drafting quality agreements, managing change control systems, and holding third-party vendors (OEMs, labs, consultants) accountable.
- Communication: Exceptional written and spoken English skills with the ability to interface confidently with executives, technical engineers, and regulatory parties.
- Availability: Capability to work flexible remote/hybrid hours with coverage across Australian and Chinese business hours.
Preferred Skills (Nice to Have)
- Direct experience with Australian medical device sponsor obligations and regulatory submission frameworks.
- Practical experience managing overseas contract manufacturing (OEM/ODM) relationships.
- Proficiency in ISO 14971 (Risk Management), post-market surveillance, and medical device vigilance.
- Hands-on experience configuring or utilizing Odoo ERP or similar eQMS and enterprise project management tools.
- Formal certifications such as ISO 13485 Lead/Internal Auditor or PMP credentials.
Benefits
Benefits
- Competitive salary based on experience and skill set
- 100% remote role — work from home anywhere in the Philippines
- Paid local holidays aligned with the Australian business calendar
- Opportunities for training and professional growth
- Work directly with a supportive Australian team — no agency middleman
- Long-term engagement with a stable and growing business