Quality Assurance Manager – Medical Devices

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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 overarching commercial timelines • Chair routine project meetings, issue actionable tracking registers, and actively mitigate project delays, risks, and critical-path bottlenecks • Maintain a central project document register and evidence tracker, escalating material risks and strategic decisions to executive management • Establish a proportionate quality-management framework governing sponsor responsibilities and quality divisions between the organization and external legal manufacturers • Negotiate and manage Quality Agreements with OEM partners, overseeing ISO 13485 certification statuses, supplier scorecards, and audit findings • Establish and manage quality procedures covering change controls, CAPAs, complaint handling, adverse-event escalations, product recalls, and post-market surveillance • Verify that no material product, software, or manufacturing process change occurs without rigorous review and impact assessments • Translate project and quality requirements into workflows within Odoo Projects, Documents, Quality, Purchase, Inventory, and Approvals modules • Build operational dashboards monitoring milestone progress, regulatory deliverables, non-conformances, CAPAs, and budget utilization • Coordinate launch-readiness across procurement, logistics, inventory distribution, and product traceability, including serial numbers, batches, and accessories

🎯 Requirements

• Minimum of 5 years of professional experience in medical devices, pharmaceuticals, or highly regulated healthcare environments • Demonstrated track record managing complex product development projects • Practical understanding of ISO 13485 quality management systems • Expertise in supplier qualification and drafting quality agreements • Experience managing change control systems • Experience holding third-party vendors, including OEMs, labs, and consultants, accountable • Exceptional written and spoken English skills • Ability to interface confidently with executives, technical engineers, and regulatory parties • Capability to work flexible remote/hybrid hours covering Australian and Chinese business hours • Direct experience with Australian medical device sponsor obligations and regulatory submission frameworks preferred • Practical experience managing overseas contract manufacturing OEM/ODM relationships preferred • Proficiency in ISO 14971, post-market surveillance, and medical device vigilance preferred • Hands-on experience configuring or utilizing Odoo ERP or similar eQMS and enterprise project management tools preferred • ISO 13485 Lead/Internal Auditor or PMP credentials preferred

🏖️ Benefits

• Competitive salary based on experience and skill set • 100% remote role — work from home anywhere in the Philippines • Paid local holidays aligned with the Australian business calendar • Opportunities for training and professional growth • Work directly with a supportive Australian team — no agency middleman • Long-term engagement with a stable and growing business