Medical Device Project & Quality Manager

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🔥 18 minutes ago

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Hunt St

WebsiteLinkedInAll Job Openings

1 - 10 employees

🎯 Recruiter

👥 HR Tech

🤝 B2B

Recruitment • HR Tech • B2B

Hunt St is an Australia-based recruiting firm founded by brothers Shaun and Eliot with the aim of helping small and medium-sized enterprises (SMEs) hire top offshore talent directly, avoiding the high costs associated with traditional outsourcing agencies. The company offers a unique one-time finder's fee model, enabling clients to save significantly on recruitment costs. They provide comprehensive services including job postings, candidate screenings, interviews, and legal support for compliant remote hiring. Hunt St specializes in sourcing talent from countries like the Philippines, Nepal, Indonesia, and India, offering a transparent and ethical hiring process that allows businesses to provide fairer compensation to employees while ensuring stringent security and compliance measures are met.

📋 Description

• 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 action registers • Maintain project documentation, evidence trackers, and reporting dashboards • Escalate key risks and decisions to executive leadership • Establish and maintain sponsor-side quality processes and documentation • Support quality governance with external manufacturing partners • Develop and manage quality agreements with suppliers and manufacturers • Oversee document control, change control, supplier qualification, complaint handling, CAPA, product recalls, post-market surveillance, and product release processes • Manage outsourced manufacturers and critical supplier relationships • Review supplier quality documentation, certifications, audits, and corrective actions • Monitor supplier performance, timelines, documentation, and compliance • Coordinate supplier audits and quality reviews • Assess and control product or manufacturing changes • Implement project and quality workflows in ERP/project management platforms such as Odoo • Develop dashboards covering project milestones, regulatory deliverables, supplier performance, quality issues, CAPAs, product changes, and testing progress • Improve documentation processes for audit and regulatory readiness • Train team members on quality and project workflows • Support product launch and market release preparation • Establish processes for product traceability, inventory control, complaints, returns, and recalls • Coordinate readiness across manufacturing, logistics, distribution, and customer support teams • Ensure documentation and operational processes are ready before commercialisation • Drive project milestones, quality and regulatory documentation completion, supplier/OEM performance, workflow implementation, reduction of overdue actions and quality gaps, and readiness for regulatory submission and commercial launch

🎯 Requirements

• Philippines-based candidate • 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 • Experience supporting Australian medical device regulatory requirements is highly desirable • Knowledge of medical device sponsor obligations is highly desirable • Experience with international OEM manufacturers, particularly in Asia, is highly desirable • Understanding of ISO 14971 risk management principles is highly desirable • Experience with post-market surveillance and vigilance processes is highly desirable • Experience using ERP systems, eQMS platforms, or project management tools such as Odoo is highly desirable • ISO 13485 internal auditor or lead auditor training is highly desirable • Experience supporting regulatory submissions and commercial launch activities is highly desirable • Must disclose existing ongoing roles or client work • Must reflect this engagement on LinkedIn as “Independent Contractor”

🏖️ Benefits

• 100% remote work • Work from home • Flexible time management as an independent contractor • Opportunity to grow into a senior leadership position overseeing quality, operations, and medical device programs