Medical Device Project & Quality Manager - (17-1193)

​​Looking for Philippines-based candidates

Job Role: Medical Device Project & Quality Manager

Compensation range: AUD $2,000 - $3,000 / Monthly

Engagement type: Independent Contractor Agreement

Work Schedule: This role is expected to align with the AU business hours (approx. 9 AM - 5 PM, Monday to Friday) for collaboration, but as a contractor, you’ll have flexibility in how you manage your time.

Who We Are: At Hunt St , we help Australian companies hire top remote talent in the Philippines. For this role, you will be engaged directly by the client as an independent contractor. We are not an outsourcing agency. All of our roles are 100% remote, so you'll be able to work from home.

Who The Client Is: Our client is an Australian healthcare technology company developing innovative regulated medical products through global manufacturing partnerships. They are currently preparing for commercialisation of a medical device and are looking for an experienced professional who can help establish strong project governance, quality systems, and supplier oversight.

The company operates in a fast-moving environment where innovation, compliance, and commercial outcomes must work together. This role provides an opportunity to work closely with executive leadership, international manufacturing partners, regulatory specialists, and external suppliers to bring a medical device from development through to market readiness.

Role Overview: The Medical Device Project & Quality Manager will take ownership of coordinating the development and commercialisation program for a regulated medical device.

This is a hands-on role combining project management, quality assurance, supplier governance, and operational readiness. You will be responsible for maintaining the overall project plan, ensuring quality requirements are met, managing external manufacturing relationships, and establishing internal processes to support regulatory compliance and future growth.

The successful candidate will play a key role in ensuring the business is prepared for product launch by implementing practical quality workflows, maintaining documentation standards, and supporting collaboration between internal teams and external manufacturing partners.
Key Responsibilities:
Project & Program Management

- Own and maintain the integrated project plan, timelines, milestones, and deliverables.

- Coordinate activities across internal teams, suppliers, consultants, and manufacturing partners.

- Track project risks, dependencies, delays, and critical activities.

- Facilitate project meetings and maintain clear action registers.

- Maintain project documentation, evidence trackers, and reporting dashboards.

- Escalate key risks and decisions to executive leadership.

Medical Device Quality Oversight

- Establish and maintain sponsor-side quality processes and documentation.

- Support quality governance between the business and external manufacturing partners.

- Develop and manage quality agreements with suppliers and manufacturers.

- Oversee processes relating to:

- Document control

- Change control

- Supplier qualification

- Complaint handling

- Corrective and preventive actions (CAPA)

- Product recalls

- Post-market surveillance

- Product release processes

Supplier & OEM Management

- Manage relationships with outsourced manufacturers and critical suppliers.

- Review supplier quality documentation, certifications, audits, and corrective actions.

- Monitor supplier performance, timelines, documentation, and compliance.

- Coordinate supplier audits and quality reviews where required.

- Ensure product or manufacturing changes are assessed and appropriately controlled.

Systems & Process Implementation

- Support implementation of project and quality workflows within ERP/project management platforms such as Odoo.

- Develop dashboards and reporting systems covering:

- Project milestones

- Regulatory deliverables

- Supplier performance

- Quality i