Quality Assurance Manager – Medical Devices

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

📋 Description

• Take ownership of and uphold the integrated project plan, ensuring that cross-functional deliverables, milestones, and dependencies align with overall commercial timelines.

• Lead regular project meetings, produce actionable tracking registers, and proactively address project delays, risks, and critical-path bottlenecks.

• Maintain a centralized project document register and evidence tracker, escalating significant risks and strategic decisions to executive management.

• Create a balanced quality-management framework that outlines sponsor responsibilities and quality divisions between the organization and external legal manufacturers.

• Negotiate and oversee Quality Agreements with OEM partners, managing ISO 13485 certification statuses, supplier scorecards, and audit outcomes.

• Develop and administer quality procedures encompassing change controls, CAPAs, complaint resolution, adverse-event escalations, product recalls, and post-market surveillance.

• Ensure that no significant changes to products, software, or manufacturing processes occur without comprehensive review and impact assessments.

• Convert project and quality requirements into workflows within Odoo Projects, Documents, Quality, Purchase, Inventory, and Approvals modules.

• Create operational dashboards to monitor 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

• A minimum of 5 years of professional experience in medical devices, pharmaceuticals, or highly regulated healthcare settings.

• Proven track record in managing complex product development projects.

• Practical knowledge of ISO 13485 quality management systems.

• Expertise in supplier qualification and the drafting of quality agreements.

• Experience in managing change control systems.

• Proven ability to hold third-party vendors, including OEMs, labs, and consultants, accountable.

• Exceptional verbal and written communication skills in English.

• Ability to confidently interface with executives, technical engineers, and regulatory stakeholders.

• Flexibility to work remote/hybrid hours covering Australian and Chinese business hours.

• Direct experience with Australian medical device sponsor obligations and regulatory submission processes is preferred.

• Practical experience in managing overseas contract manufacturing OEM/ODM relationships is preferred.

• Proficiency in ISO 14971, post-market surveillance, and medical device vigilance is preferred.

• Hands-on experience with configuring or utilizing Odoo ERP or similar eQMS and enterprise project management tools is preferred.

• ISO 13485 Lead/Internal Auditor or PMP credentials are preferred.

🏝️ Benefits

• Competitive salary based on experience and skill set.

• 100% remote role — work from home from anywhere in the Philippines.

• Paid local holidays in line with the Australian business calendar.

• Opportunities for training and professional development.

• Collaborate directly with a supportive Australian team — no agency middleman involved.

• Long-term engagement with a stable and growing business.