Remote Medical Device Project & Quality Lead

Hunt St; Philippines; Remote; PHP 958,000 - 1,438,000; Full time

Job summary

Hunt St in Philippines is seeking a Medical Device Project & Quality Manager for an independent contractor engagement. The role aligns with AU business hours and operates fully remote from home.

You will drive the development and commercialization program for a regulated medical device and work directly with the client and executive leadership. The position requires deep expertise in project management, quality systems, supplier governance, and regulatory readiness, with a focus on ISO 13485 and

Qualifications

• 5+ years in medical devices or regulated healthcare products.
• Experience leading project, quality, or regulatory initiatives.
• Strong understanding of ISO 13485.
• Experience with supplier qualification, CAPA, and change control.
• Experience with outsourced manufacturers and OEMs.
• Excellent documentation and coordination skills.
• Strong written and verbal English communication.

Responsibilities

• Own and maintain integrated project plan with milestones.
• Coordinate activities across internal teams, suppliers, and partners.
• Manage quality governance and supplier quality documents.
• Develop quality agreements and CAPA programs.
• Oversee document control, change control, and recalls.
• Implement ERP/workflows (e.g., Odoo) for project data.
• Prepare readiness activities for product launch.
• Ensure regulatory and audit readiness.

Skills

Project management

Quality assurance

ISO 13485

Supplier qualification

CAPA

Change control

Document control

Stakeholder coordination

English proficiency

Tools

Odoo

Job description

Hunt St in Philippines is seeking a Medical Device Project & Quality Manager for an independent contractor engagement. The role aligns with AU business hours and operates fully remote from home.

You will drive the development and commercialization program for a regulated medical device and work directly with the client and executive leadership. The position requires deep expertise in project management, quality systems, supplier governance, and regulatory readiness, with a focus on ISO 13485 and