Ap - Quality Assurance Manager (Medical Devices)

D2B; Philippines; Remote; PHP 1,200,000 - 1,600,000; Full time

Benefits offered by this job

100% remote — Philippines

Paid local holidays aligned with AU

Professional growth opportunities

Work with Australian team

Long-term engagement

Job summary

D2b is seeking a Medical Device Project & Quality Manager to lead integrated program execution, sponsor-side quality oversight, and regulatory deliverables across Asia-Pacific business hours in a remote setting.

The role bridges product innovation and commercial delivery, with a pathway toward executive operations leadership as the technology portfolio expands, offering a dynamic, global impact role.

Qualifications

• Minimum of 5 years in medical devices, pharmaceuticals, or highly regulated healthcare environments.
• Demonstrated track record managing complex product development projects with ISO 13485 systems.
• Proven expertise in supplier qualification, quality agreements, change control, and vendor accountability.
• Exceptional written and spoken English interfacing with executives, engineers, and regulatory parties.
• Able to work flexible remote/hybrid hours across Australian and Chinese business hours.

Responsibilities

• Own and maintain the integrated project plan with cross-functional milestones and dependencies.
• Chair routine project meetings, track issues, and mitigate delays and risks.
• Maintain a central document register and escalate material risks to executives.
• Establish quality-management framework for sponsor responsibilities and manage supplier governance.
• Negotiate and manage Quality Agreements with OEM partners and oversee ISO 13485 statuses and audits.
• Implement change controls, CAPAs, complaints handling, adverse-event escalations, recalls, and PMS.
• Ensure no material changes occur without rigorous review and impact assessments.
• Translate requirements into workflows in systems like Odoo (Projects, Documents, Quality, Purchase, Inventory, Approvals).
• Build dashboards monitoring milestones, regulatory deliverables, non-conformances, CAPAs, and budget.
• Coordinate launch-readiness across procurement, logistics, inventory, and traceability.

Skills

Experience in medical devices

ISO 13485 knowledge

Vendor governance

Excellent English communication

Availability across ANZ/China hours

Job description

AP - Quality Assurance Manager (Medical Devices)

Company: D2b Job Type: Full Time Remote / Work from Home

Note: This is for active pooling purposes only. Submitting your application does not guarantee employment. Your details will be kept on file and considered for future opportunities as they become available.

We are looking for a Medical Device Project & Quality Manager, you will lead integrated program execution, establish sponsor-side quality controls, and drive key regulatory deliverables across Asia-Pacific business hours. This critical position bridges product innovation and commercial delivery, offering a clear accelerated pathway toward executive operations leadership as the company expands its technology portfolio.

Responsibilities

Program Management & Execution

• 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.

Sponsor-Side Quality Oversight & Supplier Governance

• Establish a proportionate quality-management framework to govern sponsor responsibilities, defining clear quality divisions between the organization and external legal manufacturers.
• Negotiate and manage Quality Agreements with OEM partners, maintaining strict oversight of ISO 13485 certification statuses, supplier scorecards, and audit findings.
• Establish and manage core quality procedures, including change controls, CAPAs, complaint handling, adverse-event escalations, product recalls, and post-market surveillance.
• Ensure strict verification that no material product, software, or manufacturing process change occurs without rigorous review and impact assessments.

Systems & Operations Integration

• Translate project and quality requirements into practical workflows within Odoo (covering Projects, Documents, Quality, Purchase, Inventory, and Approvals modules).
• Build operational dashboards to monitor milestone progress, regulatory deliverables, non-conformances, CAPAs, and budget utilization.
• Coordinate operational launch-readiness across procurement, logistics, inventory distribution, and product traceability (serial numbers, batches, and accessories).

Requirements

Qualifications (Must-Haves)

• Experience: Minimum of 5 years of professional experience in medical devices, pharmaceuticals, or highly regulated healthcare environments.
• Domain Knowledge: Demonstrated track record managing complex product development projects and a practical understanding of ISO 13485 quality management systems.
• Vendor Governance: Proven expertise in supplier qualification, drafting quality agreements, managing change control systems, and holding third-party vendors (OEMs, labs, consultants) accountable.
• Communication: Exceptional written and spoken English skills with the ability to interface confidently with executives, technical engineers, and regulatory parties.
• Availability: Capability to work flexible remote/hybrid hours with coverage across Australian and Chinese business hours.

Preferred Skills (Nice to Have)

• Direct experience with Australian medical device sponsor obligations and regulatory submission frameworks.
• Practical experience managing overseas contract manufacturing (OEM/ODM) relationships.
• Proficiency in ISO 14971 (Risk Management), post-market surveillance, and medical device vigilance.
• Hands-on experience configuring or utilizing Odoo ERP or similar eQMS and enterprise project management tools.
• Formal certifications such as ISO 13485 Lead/Internal Auditor or PMP credentials.

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