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 issues
• CAPAs
• Product changes
• Testing progress
• Improve documentation processes to ensure audit and regulatory readiness.
• Train team members on quality and project workflows.

Commercial & Operational Readiness

• Support preparation for product launch and market release.
• Establish processes for product traceability, inventory control, complaints, returns, and recalls.
• Coordinate readiness activities across manufacturing, logistics, distribution, and customer support teams.
• Ensure documentation and operational processes are ready before commercialisation.

Required Skills and Qualifications:

• 5+ years of experience within medical devices, pharmaceuticals, healthcare products, or another regulated industry.
• Proven experience managing complex product development, quality, or regulatory projects.
• Strong understanding of ISO 13485 quality management principles.
• Experience with supplier qualification, quality agreements, CAPA, change control, and complaint handling.
• Experience working with outsourced manufacturers, OEMs, suppliers, or laboratories.
• Strong project management and stakeholder coordination skills.
• Excellent documentation, organisation, and follow-up abilities.
• Ability to independently manage priorities and drive accountability across external partners.
• Strong written and verbal English communication skills.

Highly Desirable Experience

• Experience supporting Australian medical device regulatory requirements.
• Knowledge of medical device sponsor obligations.
• Experience working with international OEM manufacturers, particularly in Asia.
• Understanding of ISO 14971 risk management principles.
• Experience with post-market surveillance and vigilance processes.
• Experience using ERP systems, eQMS platforms, or project management tools such as Odoo.
• ISO 13485 internal auditor or lead auditor training.
• Experience supporting regulatory submissions and commercial launch activities.

Personal Attributes

• Highly accountable with strong ownership of outcomes.
• Comfortable managing multiple stakeholders and competing priorities.
• Confident holding suppliers and external partners accountable.
• Detail-oriented while maintaining focus on business objectives.
• Practical, commercially minded, and solutions-focused.
• Comfortable working directly with executives, engineers, consultants, and manufacturers.
• Able to create structure and processes in a fast-moving environment.

Success Measures

Success in this role will be measured by:

• Delivery of project milestones against agreed timelines.
• Completion of quality and regulatory documentation requirements.
• Effective supplier and OEM performance management.
• Implementation of project and quality workflows.
• Reduction of overdue actions and quality gaps.
• Readiness for regulatory submission and commercial launch.
• Successful transition from development into market release.

Career Growth

This role offers the opportunity to grow into a senior leadership position overseeing quality, operations, and medical device programs as the company expands its regulated product portfolio.

Work Arrangement & Expectations:

This is a remote role that will be set up as an independent contractor engagement.

To ensure alignment and transparency, successful candidates will be expected to:

• Disclose any existing ongoing roles or client work
• Reflect this engagement on their LinkedIn profile (clearly marked as “Independent Contractor”)