Quality Control Manager

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

Benefits offered by this job

Medical

Dental

Vision

Flexible Spending Account

Basic Life

401(k) Retirement Plan

Paid Holidays

PTO

Maternity/Paternity paid leave

Job summary

4C Medical Tech is seeking a Quality Control Manager to lead day-to-day QC operations for highly specialized medical device manufacturing, including tissue processing, valve assembly, and Nitinol frame work.

You will oversee inspection, testing, compliance, and quality activities across complex processes, while guiding a team of five quality professionals toward audit readiness and successful regulatory approvals.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, or related field.
• 7+ years in quality control/quality engineering in medical devices.
• Experience with FDA-regulated manufacturing, 21 CFR 820, ISO 13485.
• Experience leading investigations, CAPA, root-cause analysis.
• Experience mentoring quality professionals.
• Strong inspection, testing, process controls in manufacturing.
• Hands-on, fast-paced environment with multiple priorities.

Responsibilities

• Oversee daily QC inspection, testing, and release operations for finished devices.
• Drive quality oversight for tissue processing, valve assembly, and related processes.
• Maintain audit readiness with regulatory documentation and traceability.
• Lead investigations, non-conformances, CAPA, and root-cause analysis.
• Mentor QC team and coordinate training matrices for specialized processes.
• Oversee environmental monitoring, bioburden testing, and cleanroom compliance.
• Support supplier quality through SCARs and incoming inspection criteria.

Skills

Quality oversight

Leadership

FDA 21 CFR 820

ISO 13485

CAPA investigations

Training & mentoring

Inspection & testing

Education

Bachelor’s degree in Engineering/Life Sciences/Quality

Job description

Description

WHO WE ARE

We are a growing medical device company developing innovative technology to transform the treatment of mitral valve disease. Our team is advancing a Class III structural heart device through pivotal clinical trials, with a shared focus on delivering a high-quality product that can make a meaningful difference for patients.

At 4C Medical, you’ll find an environment where your ideas matter, your growth is prioritized, and your contributions directly influence our success. We’re committed to fostering both personal and professional development in a culture built on accountability, curiosity, and shared purpose.

THE OPPORTUNITY

We are seeking a Quality Control Manager to lead day-to-day QC operations for our highly specialized medical device manufacturing environment. This is a hands-on leadership opportunity where you will oversee inspection, testing, compliance, and quality activities across complex processes including tissue processing, valve assembly, Nitinol frame shape-setting, delivery system fabrication, and cleanroom packaging.

You will lead a team of five quality engineering and inspection professionals while helping ensure the organization remains audit-ready as we progress toward commercial approvals in the U.S., Europe, and Canada.

HOW YOU WILL CONTRIBUTE

• QC Operations & Assembly Support: Oversee daily inspection, testing, and release operations for raw materials, in-process components, and finished sterile devices. Drive rigorous quality oversight for the high-precision tissue-to-frame sewing and valve assembly processes.
• Audit Readiness & Compliance: Maintain a continuous state of audit readiness across the QC footprint. Ensure documentation, traceabilities, and processing environments comply with FDA, CE Mark, and Health Canada regulations.
• Non-Conformance & CAPA Management: Own the investigation, root-cause analysis, and disposition of non-conformances (NCMRs) and deviations. Directly handle failures or anomalies identified during complex valve assembly and sewing operations.
• Team Leadership & Development: Directly manage, mentor, and resource-load the QC team. Partner with the Quality Training Coordinator to ensure the highly specialized training and qualification matrices required for valve sewing and assembly are meticulously maintained.
• Process & Environmental Control: Oversee environmental monitoring, bioburden testing, and cleanroom compliance for the in-house tissue fixation, processing, and device assembly lines.
• Supplier Quality Oversight: Support the Sr. Supplier Quality Engineer in managing critical component vendors, resolving supplier corrective actions (SCARs), and coordinating incoming inspection criteria.

Requirements

WHAT YOU NEED TO SUCCEED (MINIMUM QUALIFICATIONS)

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical field.
• 7+ years of experience in quality control, quality engineering, manufacturing quality, or a related medical device environment.
• Experience working within FDA-regulated medical device manufacturing and a strong understanding 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.
• Strong understanding of inspection, testing, process controls, and quality systems within a manufacturing environment.
• Ability to work effectively in a hands-on, fast-paced environment and manage multiple priorities.

WHAT WILL SET YOU APART (COMPETENCIES)

• Experience with Class III medical devices, particularly implantable or structural heart products.
• Experience with tissue processing, tissue sewing, valve assembly, or other highly specialized medical device manufacturing processes.
• Experience supporting pivotal clinical trials and/or commercialization activities.
• Familiarity with MDSAP, CE Mark, and Health Canada regulatory requirements.
• Experience working in cleanroom environments and with environmental monitoring or bioburden testing.
• Strong leadership and team development skills with the ability to balance hands-on problem solving with strategic thinking.
• Excellent communication and collaboration skills with the ability to influence across functions.
• Demonstrated ability to thrive in an entrepreneurial environment where priorities can evolve and individuals are expected to roll up their sleeves and get things done.

WHY JOIN US

We recognize that meaningful work is supported by meaningful benefits. That’s why we offer a competitive compensation package along with comprehensive benefits designed to support you and your family’s health, well-being, and financial future.Our benefits package includes:

• Medical
• Dental
• Vision
• Flexible Spending Account (FSA)
• Basic Life
• 401(k) Retirement Plan
• Paid Holidays
• PTO
• Maternity/Paternity paid leave

It is 4C Medical’s policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state or local laws.