Medical Device Project & Quality Manager

This is a fully remote position, open to applicants in Philippines.

📋 Description

• Take ownership of and uphold the integrated project plan, including timelines, milestones, and deliverables.

• Coordinate activities among internal teams, suppliers, consultants, and manufacturing partners.

• Monitor project risks, dependencies, delays, and critical activities.

• Facilitate project meetings and keep action registers updated.

• Manage project documentation, evidence trackers, and reporting dashboards.

• Raise significant risks and decisions to executive leadership.

• Establish and maintain quality processes and documentation on the sponsor side.

• Assist with quality governance alongside external manufacturing partners.

• Develop and oversee quality agreements with suppliers and manufacturers.

• Supervise document control, change control, supplier qualification, complaint handling, CAPA, product recalls, post-market surveillance, and product release processes.

• Manage relationships with outsourced manufacturers and critical suppliers.

• Evaluate supplier quality documentation, certifications, audits, and corrective actions.

• Track supplier performance, timelines, documentation, and compliance.

• Organize supplier audits and quality reviews.

• Assess and manage product or manufacturing changes.

• Implement project and quality workflows in ERP/project management platforms, such as Odoo.

• Create dashboards that highlight project milestones, regulatory deliverables, supplier performance, quality issues, CAPAs, product changes, and testing progress.

• Enhance documentation processes for audit and regulatory readiness.

• Provide training to team members on quality and project workflows.

• Assist with product launch and market release preparations.

• Develop processes for product traceability, inventory control, complaints, returns, and recalls.

• Coordinate readiness across manufacturing, logistics, distribution, and customer support teams.

• Ensure that documentation and operational processes are in place prior to commercialization.

• Propel project milestones, completion of quality and regulatory documentation, supplier/OEM performance, workflow implementation, reduction of overdue actions and quality gaps, and readiness for regulatory submission and commercial launch.

⛳️ Requirements

• Candidate must be based in the Philippines.

• Minimum of 5 years of experience in medical devices, pharmaceuticals, healthcare products, or another regulated industry.

• Demonstrated experience managing complex product development, quality, or regulatory projects.

• Strong knowledge of ISO 13485 quality management principles.

• Familiarity with supplier qualification, quality agreements, CAPA, change control, and complaint handling.

• Experience collaborating with outsourced manufacturers, OEMs, suppliers, or laboratories.

• Excellent project management and stakeholder coordination abilities.

• Strong documentation, organization, and follow-up skills.

• Capable of independently managing priorities and fostering accountability among external partners.

• Proficient in written and verbal English communication.

• Experience supporting Australian medical device regulatory requirements is highly advantageous.

• Understanding of the obligations of medical device sponsors is highly desirable.

• Experience with international OEM manufacturers, especially in Asia, is highly favorable.

• Knowledge of ISO 14971 risk management principles is highly desirable.

• Experience in post-market surveillance and vigilance processes is highly advantageous.

• Familiarity with ERP systems, eQMS platforms, or project management tools like Odoo is highly desirable.

• ISO 13485 internal auditor or lead auditor training is highly favorable.

• Experience assisting with regulatory submissions and commercial launch activities is highly desirable.

• Must disclose any ongoing roles or client engagements.

• Must represent this engagement on LinkedIn as “Independent Contractor.”

🏝️ Benefits

• 100% remote work opportunity.

• Work from home.

• Flexible time management as an independent contractor.

• Potential for career advancement into a senior leadership role overseeing quality, operations, and medical device programs.