Medical Device Project & Quality Manager

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Pear Tree.

WebsiteLinkedInAll 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.

📋 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 • Preferred: ISO 13485 Lead/Internal Auditor or PMP certifications