Quality Manager

Job Description

Job Description

The Quality Manager is responsible for leading and maintaining a compliant, audit‐ready ISO 13485 Quality Management System while ensuring consistent delivery of high‐precision, medical‐grade components. This role oversees all quality functions—including inspection, metrology, document control, CAPA, supplier quality, and customer quality—and drives a culture of accountability, continuous improvement, and documentation discipline across the organization.

Key Responsibilities

Quality Management System

• Maintain and improve the QMS in compliance with ISO 13485, FDA QSR (21 CFR 820), and customer‐specific requirements.

• Ensure all procedures, work instructions, forms, and records are controlled, current, and properly implemented.

• Lead internal audits, management reviews, and readiness for customer and regulatory audits.

Inspection & Metrology

• Oversee incoming, in‐process, and final inspection activities.

• Manage calibration, gage control, and metrology equipment (CMMs, vision systems, hand tools).

• Ensure proper use of GD&T, sampling plans, and inspection documentation.

CAPA, NCR, and Root Cause

• Lead structured root‐cause investigations using 5‐Why, Fishbone, DMAIC, or similar tools.

• Drive timely and effective CAPA implementation, verification, and closure.

• Manage nonconformances, deviations, concessions, and customer notifications.

Customer & Supplier Quality

• Serve as the primary point of contact for customer quality issues, audits, and source inspections.

• Manage supplier evaluations, audits, scorecards, and corrective actions.

• Support customer documentation requirements (FAIRs, PPAP, validation, risk management).

Team Leadership

• Lead, mentor, and develop Quality Inspectors, Document Control, and Quality Engineers.

• Set clear expectations, provide coaching, and ensure accountability for performance and documentation accuracy.

• Build a culture of quality, compliance, and continuous improvement.

Quality Metrics & Reporting

• Track and report KPIs: scrap, rework, yield, audit findings, customer complaints, and CAPA performance.

• Present quality performance to leadership and drive data‐based improvement initiatives.

Qualifications

• 5+ years of quality experience in medical device manufacturing, precision machining, or regulated production.

• Strong knowledge of ISO 13485, FDA QSR, and GD&T.

• Experience leading audits, managing CAPA, and maintaining a compliant QMS.

• Proficiency with metrology tools, CMMs, and inspection software.

• Demonstrated leadership ability in a fast‐paced manufacturing environment.

• Excellent communication, documentation, and problem‐solving skills.

• Bachelor’s degree in Engineering, Quality, or related field preferred.

What Success Looks Like

• Audit‐ready at all times—no surprises.

• Strong documentation discipline across the shop.

• Effective, timely CAPA closures with verified results.

• Reduced scrap, rework, and customer escalations.

• High customer confidence and strong supplier performance.

• A well‐trained, accountable, high‐performing Quality team.

EMPRO is a premier staffing firm specializing in placing top-tier manufacturing and technical talent. Known for speed, precision, and quality, EMPRO delivers highly qualified candidates quickly—saving companies time while ensuring the right fit every time. EMPRO partners closely with both clients and candidates to create long-term, successful placements.

Company Description

EMPRO is a premier staffing firm specializing in placing top-tier manufacturing and technical talent. Known for speed, precision, and quality, EMPRO delivers highly qualified candidates quickly—saving companies time while ensuring the right fit every time. EMPRO partners closely with both clients and candidates to create long-term, successful placements.