Hunt St
Application Process To ensure your application is reviewed, please submit your application through our official recruitment platform. Apply here: https://apply.workable.com/hunt-st/j/8E5DCF14CD Please note: Applications submitted through Indeed will not be reviewed. Only applications submitted through the application link above will be considered as part of our recruitment process. Medical Device Project & Quality Manager (Remote) Location: Philippines (Remote) Job Type: Full-Time | Independent Contractor Compensation AUD $2,000 – $3,000 per month Work Schedule: Australian business hours (approximately 9:00 AM – 5:00 PM, Monday to Friday) with flexibility in managing your working hours. About the Opportunity We are looking for an experienced Medical Device Project & Quality Manager to support an Australian healthcare technology company preparing for the commercial launch of a regulated medical device. This role combines project management, quality assurance, supplier management, and operational readiness. You'll work closely with executive leadership, international manufacturing partners, regulatory specialists, and suppliers to ensure projects remain on track while maintaining compliance with quality and regulatory requirements. This is a fully remote opportunity for professionals based in the Philippines. About the Business Our client is an Australian healthcare technology company developing innovative regulated medical devices through global manufacturing partnerships. As the business prepares for commercialisation, they are looking for someone who can build strong quality systems, manage project delivery, and support successful product launch activities. Key Responsibilities Project Management Manage project plans, timelines, milestones, and deliverables Coordinate activities across internal teams, suppliers, consultants, and manufacturing partners Track project risks, dependencies, and progress Facilitate project meetings and maintain action registers Prepare project reports, dashboards, and documentation Escalate key risks and project updates to leadership Quality Management Develop and maintain quality management processes and documentation Support compliance with ISO 13485 quality management principles Develop and manage supplier quality agreements Oversee: Document control Change control Supplier qualification CAPA (Corrective and Preventive Actions) Complaint handling Product recalls Post-market surveillance Product release activities Supplier & Manufacturing Management Manage relationships with manufacturers, OEM partners, laboratories, and suppliers Review supplier quality documentation, certifications, and audit findings Monitor supplier performance and compliance Coordinate supplier audits and quality reviews Ensure manufacturing or product changes follow appropriate quality processes Systems & Process Improvement Support implementation of project and quality workflows using platforms such as Odoo or similar systems Develop dashboards to monitor: Project milestones Supplier performance CAPAs Regulatory deliverables Product changes Testing progress Improve documentation and quality processes Train internal team members on quality and project workflows Commercial Readiness Support product launch planning and commercial readiness Establish processes for product traceability, inventory management, complaints, returns, and recalls Coordinate readiness across manufacturing, logistics, distribution, and customer support Ensure operational and quality documentation is complete before product launch Requirements Minimum 5 years' experience in medical devices, pharmaceuticals, healthcare products, or another regulated industry Experience managing complex product development, quality, or regulatory projects Strong knowledge of ISO 13485 Experience with: Supplier qualification Quality agreements CAPA Change control Complaint handling Experience working with outsourced manufacturers, OEMs, suppliers, or testing laboratories Strong project management and stakeholder management skills Excellent documentation, organisational, and communication skills Ability to manage multiple priorities independently Excellent written and spoken English Highly Desirable 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 activities Experience using ERP systems, eQMS platforms, or project management software such as Odoo ISO 13485 Internal Auditor or Lead Auditor training Experience supporting regulatory submissions and commercial product launches What We're Looking For We're looking for someone who is: Highly organised and accountable Comfortable working directly with senior leaders and external partners Detail-oriented while maintaining a commercial mindset Confident managing suppliers and driving accountability Proactive, solutions-focused, and able to build structure in a growing business Work Arrangement Fully remote role Full-time Independent Contractor engagement Flexible working arrangement aligned with Australian business hours Opportunity to work closely with executive leadership on a high-impact medical device program Strong potential for long-term career growth as the business expands Successful candidates will be expected to: Disclose any existing ongoing roles or client work Maintain transparency regarding current work commitments Reflect this engagement on their LinkedIn profile as an Independent Contractor About Hunt St Hunt St helps Australian companies hire talented remote professionals in the Philippines. For this role, you'll be engaged directly by the client as an Independent Contractor and will work as part of their growing team. Pay: Php85,500.00 - Php128,000.00 per month Benefits Pay raise Work from home Work Location: Remote
Hunt St
