# AP - Quality Assurance Manager (Medical Devices)

**Company:** [D2B](http://jobs.workable.com/companies/dcaVtKQqXr9FwBNppNCBH9.md)
**Location:** Remote
**Workplace:** remote
**Employment type:** Full-time
**Department:** Active Pooling - Sourcing

[Apply for this job](http://jobs.workable.com/view/47fac0de-26b5-4d3e-9d7b-8d7b1b873b72)

## Description

_**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