Medical Device Project & Quality Manager

Pear Tree.

Medical device project and quality manager for an Australian healthcare business. Leading regulated product delivery, sponsor-side quality, supplier governance, and launch readiness across Asia-Pacific hours.

Posted 8/6/2026full-timeRemote • 🇵🇭 PhilippinesMid-LevelSenior💰 A$2,000 - A$3,000 per monthWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing complex product development projects within highly regulated healthcare environments, with a strong focus on ISO 13485 quality management systems and supplier governance. Proficient in utilizing Odoo ERP for project management and quality workflows, while effectively communicating with cross-functional teams and executives.

Highest-signal resume keywords

ISO 13485 Quality Management SystemsProject ManagementSupplier QualificationChange Control SystemsOdoo ERP

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project PlanningQuality ManagementRisk MitigationRegulatory ComplianceChange ControlCAPA ManagementPost-Market SurveillanceProduct DevelopmentAudit ManagementData Analysis

Soft Skills

Exceptional CommunicationCross-Functional CollaborationProblem SolvingNegotiationFlexibility

Tools & Technologies

Odoo ProjectsOdoo DocumentsOdoo QualityOdoo PurchaseOdoo InventoryOdoo Approvals

Certifications & Qualifications

ISO 13485 Lead AuditorPMP Certification

Industry Keywords

Medical DevicesPharmaceuticalsRegulatory FrameworksOEM RelationshipsQuality Agreements

Tech Stack

Tools & technologies

ERPPMP

About the role

Key responsibilities & impact

Own and maintain the integrated project plan, aligning cross-functional deliverables, milestones, and dependencies with commercial timelines
Chair routine project meetings, issue actionable tracking registers, and mitigate delays, risks, and critical-path bottlenecks
Maintain the central project document register and evidence tracker, escalating material risks and strategic decisions to executive management
Establish a proportionate quality-management framework defining quality divisions between the organization and external legal manufacturers
Negotiate and manage Quality Agreements with OEM partners
Oversee ISO 13485 certification statuses, supplier scorecards, and audit findings
Establish and manage change controls, CAPAs, complaint handling, adverse-event escalations, product recalls, and post-market surveillance procedures
Verify that material product, software, or manufacturing process changes undergo rigorous review and impact assessment
Translate project and quality requirements into workflows within Odoo Projects, Documents, Quality, Purchase, Inventory, and Approvals modules
Build dashboards monitoring milestone progress, regulatory deliverables, non-conformances, CAPAs, and budget utilization
Coordinate launch readiness across procurement, logistics, inventory distribution, and product traceability

Requirements

What you’ll need

Minimum 5 years of professional experience in medical devices, pharmaceuticals, or highly regulated healthcare environments
Demonstrated experience managing complex product development projects
Practical understanding of ISO 13485 quality management systems
Expertise in supplier qualification, quality agreements, change control systems, and third-party vendor governance
Exceptional written and spoken English skills
Ability to interface with executives, technical engineers, and regulatory parties
Capability to work flexible hours covering Australian and Chinese business hours
Preferred: Australian medical device sponsor obligations and regulatory submission frameworks
Preferred: Overseas contract manufacturing OEM/ODM relationship management
Preferred: ISO 14971, post-market surveillance, and medical device vigilance
Preferred: Odoo ERP or similar eQMS and enterprise project management tools
Preferred: ISO 13485 Lead/Internal Auditor or PMP certifications

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Pear Tree. Website LinkedIn All Job Openings 1 - 10 employees 💼 Consulting 📦 Logistics 📣 Marketing Consulting
Logistics
Marketing Pear Tree is a Melbourne‑born offshore recruitment and hiring services company that connects Australian, US, and UK businesses directly with skilled offshore professionals (primarily from the Philippines) without agency markups. They provide end-to-end hiring support — sourcing, screening, skills assessments, video interviews, reference checks — and offer payroll, Employer‑of‑Record, and compliance assistance plus a six‑month replacement guarantee. Pear Tree recruits across IT, sales & marketing, finance, creative, admin and operations roles, emphasizing cost savings, direct pay to talent, and secure onboarding workflows. Medical Device Project & Quality Manager Job not on LinkedIn 🔥 0 minutes ago 🇵🇭 Philippines – Remote 💵 A$2k - A$3k / month ⏰ Full Time 🟡 Mid-level 🟠 Senior 👷‍♀️ Project Manager Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Own and maintain the integrated project plan, aligning cross-functional deliverables, milestones, and dependencies with commercial timelines
Chair routine project meetings, issue actionable tracking registers, and mitigate delays, risks, and critical-path bottlenecks
Maintain the central project document register and evidence tracker, escalating material risks and strategic decisions to executive management
Establish a proportionate quality-management framework defining quality divisions between the organization and external legal manufacturers
Negotiate and manage Quality Agreements with OEM partners
Oversee ISO 13485 certification statuses, supplier scorecards, and audit findings
Establish and manage change controls, CAPAs, complaint handling, adverse-event escalations, product recalls, and post-market surveillance procedures
Verify that material product, software, or manufacturing process changes undergo rigorous review and impact assessment
Translate project and quality requirements into workflows within Odoo Projects, Documents, Quality, Purchase, Inventory, and Approvals modules
Build dashboards monitoring milestone progress, regulatory deliverables, non-conformances, CAPAs, and budget utilization
Coordinate launch readiness across procurement, logistics, inventory distribution, and product traceability 🎯 Requirements
Minimum 5 years of professional experience in medical devices, pharmaceuticals, or highly regulated healthcare environments
Demonstrated experience managing complex product development projects
Practical understanding of ISO 13485 quality management systems
Expertise in supplier qualification, quality agreements, change control systems, and third-party vendor governance
Exceptional written and spoken English skills
Ability to interface with executives, technical engineers, and regulatory parties
Capability to work flexible hours covering Australian and Chinese business hours
Preferred: Australian medical device sponsor obligations and regulatory submission frameworks
Preferred: Overseas contract manufacturing OEM/ODM relationship management
Preferred: ISO 14971, post-market surveillance, and medical device vigilance
Preferred: Odoo ERP or similar eQMS and enterprise project management tools
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