Assistant Quality Assurance Manager (Trumbull)

Job Summary

ZetrOZ Systems is looking for an experienced Assistant Quality Assurance Manager to lead and optimize our Quality Management System (QMS). In this role, you will ensure that our drug-free, wearable bioelectronic ultrasound therapeutics (including sam® technology) are designed, manufactured, and distributed to meet the highest safety, reliability, and regulatory standards. You will bridge engineering, manufacturing, and global regulatory compliance to maintain a culture of operational excellence and defect prevention.

Job Reporting

The Assistant Quality Assurance Manager reports directly to the Director of Regulatory and Quality Assurance.

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.

Key Skills and Qualifications

• 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.