# AP - Quality Assurance Manager (Medical Devices) at D2B

- Company: D2B
- Location: Metro Manila, Philippines (remote)
- Places: Metro Manila, Remote, Philippines
- Posted: 2026-08-06
- Apply: https://apply.workable.com/d2b-1/j/9B722A3407/
- Page: https://ye.saranatour.dev/jobs/ap-quality-assurance-manager-medical-devices-d2b-kn77nn47wrhxbymr7hydnjvvfs8hdvdg

## The posting

AP - Quality Assurance Manager (Medical Devices)
D2B · Metro Manila, Philippines

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_**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.
- Practica