Lead Product Quality Vigilance Engineer

Biopharma Careers; Philippines; On-site; PHP 7,500,000 - 10,000,000; Full time

Job summary

Johnson & Johnson is seeking a PQV Quality Engineer to lead investigations of product quality complaints for Innovative Medicine products and medical devices. You will collaborate with manufacturing sites, R&D, and regulatory bodies to ensure robust investigations and timely remediation.

The role emphasizes data-driven decision making, risk assessment, and cross-functional support across QA, compliance, and quality systems.

Qualifications

• 5+ years QA/QC in pharma or medical devices.
• Experience with complaint management and post-market vigilance.
• BA/BS in technical, scientific or engineering; Six Sigma training preferred.

Responsibilities

• Lead and support investigation of PQCs with manufacturing sites.
• Coordinate and support investigation and submission of Medical Device Reports.
• Act as SPOC for PQV at manufacturing sites and back-up other SPOCs.
• Improve methods for product investigations and data-driven decision making.
• Support internal and external audits and inspections.
• Educate/training on complaint investigation processes.

Skills

Quality Assurance

Quality Control

Regulatory requirements

Complaint Management

Post Market Vigilance

Risk Management

Project Management

Change Management

Verbal & Written Communication

Supervisory Experience

Six Sigma Green Belt

Six Sigma Black Belt / CQE

Education

BA/BS in technical, scientific or engineering disciplines

MA/MS/MBA in technical, scientific or engineering disciplines desirable

Tools

GAMP

ISO 9001

Job description

Johnson & Johnson is seeking a PQV Quality Engineer to lead investigations of product quality complaints for Innovative Medicine products and medical devices. You will collaborate with manufacturing sites, R&D, and regulatory bodies to ensure robust investigations and timely remediation.

The role emphasizes data-driven decision making, risk assessment, and cross-functional support across QA, compliance, and quality systems.