Quality Manager, MedTech - Class III Devices

4C Medical Tech; Don Mariano Marcos; On-site; PHP 900,000 - 1,800,000; Full time

Job summary

4C Medical is a growing medical device company developing innovative technology to transform the treatment of mitral valve disease. Our team advances a Class III structural heart device through pivotal clinical trials with a focus on delivering a high-quality product for patients.

We are seeking a Quality Manager to lead day-to-day QC operations, oversee inspection, testing, compliance, and CAPA across tissue processing and valve assembly, while guiding a team of five quality professionals

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical field.
• 7+ years of experience in quality control, quality engineering, or a related medical device environment.
• Experience within FDA-regulated medical device manufacturing and knowledge of 21 CFR Part 820 and ISO 13485.
• Experience leading investigations, non-conformances, CAPA, and root-cause analysis.
• Experience managing, mentoring, and developing quality professionals.

Responsibilities

• Oversee daily QC inspection, testing, and release operations for raw materials, in-process components, and finished sterile devices.
• Maintain audit readiness across the QC footprint with compliant documentation and traceability.
• Lead investigation and disposition of non-conformances and deviations, with root-cause analysis.
• Manage, mentor, and resource-load the QC team, ensuring proper training and qualifications.
• Oversee environmental monitoring, bioburden testing, and cleanroom compliance for tissue processing and device assembly.

Skills

Leadership

CAPA

Root cause analysis

Quality systems

Process controls

Education

Bachelor's degree in Engineering/Life Sciences

Job description

4C Medical is a growing medical device company developing innovative technology to transform the treatment of mitral valve disease. Our team advances a Class III structural heart device through pivotal clinical trials with a focus on delivering a high-quality product for patients.

We are seeking a Quality Manager to lead day-to-day QC operations, oversee inspection, testing, compliance, and CAPA across tissue processing and valve assembly, while guiding a team of five quality professionals