Assistant Quality Assurance Manager

Core Responsibilities: QMS Compliance & Governance: Maintain, enforce, and audit the company’s Quality Management System (QMS) in absolute compliance with FDA 21 CFR Part 820 and ISO 13485 medical device standards. Product Risk & Validation Management: Lead risk assessments, Design/Process Failure Mode and Effects Analysis (DFMEA/PFMEA), and direct validation protocols for equipment, product validation, and mass production. Audits & Regulatory Readiness: Act as the primary interface for external regulatory bodies (FDA, notified bodies). Oversee recurring internal audits, supplier audits, and global inspection readiness. CAPA & Root Cause Analysis: Investigate non-conformances, manufacturing defects, and customer returns. Implement effective Corrective and Preventive Actions (CAPA) and track closure efficiency. Supplier Quality Management: Monitor and score performance for critical component suppliers (mechanical, electrical, and integration parts). Implement advanced manufacturing quality controls such as Statistical Process Control (SPC).Performance Metrics (KPIs): Compile and present quality performance indicators—such as First Pass Yield (FPY), Rolled Throughput Yield (RTY), and Cost of Poor Quality (COPQ)—to upper management.

Education: Bachelor’s degree in Biomedical Engineering, Mechanical/Electrical Engineering, Quality Management, or a related scientific technical field.

Experience: 5+ years of quality assurance or quality systems experience strictly within the medical device or healthcare manufacturing space, with at least 2 years in a leadership or supervisory capacity. Regulatory Expertise: Deep working knowledge of medical device regulations, including FDA guidelines, ISO 13485, and IEC 60601 (Home-Use Medical Equipment safety).

Certifications: Certified Quality Manager (CQM), Certified Quality Engineer (CQE), Lead ISO Auditor, or Six Sigma Green/Black Belt credentials are highly favored.

Technical Skills: Mastery of root cause methodologies (8D, 5 Whys), statistical analysis tools, and experience managing digital CAPA/Document Control platforms.