Lead QC Manager – Medical Device Precision Machining

Cephas Consultancy Services Private Limited; West Chester (Chester County); On-site; USD 85,000 - 125,000; Full time

Job summary

Cephas Consultancy Services Private Limited in West Chester, PA, seeks a hands-on Quality Control Manager for precision-machined medical device components. You will lead inspection activities, maintain quality documentation, and support ISO 9001 and ISO 13485 compliance.

You will review jobs, develop inspection plans, perform FAIs, mentor inspectors, and drive CAPA and MRB processes to ensure product conformity and regulatory readiness.

Qualifications

• Experience in precision machining or medical device manufacturing is required.
• Strong ability to read blueprints and interpret GD&T.
• Knowledge of ISO 9001 and ISO 13485 quality systems.
• Hands-on leadership of inspection teams and MRB processes.

Responsibilities

• Lead daily quality operations for precision-machined medical device components.
• Review jobs, revisions, specifications, and customer requirements.
• Develop and maintain inspection plans, sheets, and documentation.
• Perform FAIs, in-process, and final inspections.
• Guide machinists with technical quality support and training.
• Lead MRB activities and disposition decisions.
• Investigate NCRs and customer complaints; drive CAPA.
• Maintain calibration records and SOPs; support ISO audits.

Skills

Blueprint reading

GD&T interpretation

First Article Inspections

Precision inspection equipment

ISO 9001 knowledge

ISO 13485 knowledge

Supervisory experience

Quality leadership

Education

Bachelor's degree in Engineering/Manufacturing/Quality

Tools

Micrometers

Calipers

Height gauges

Thread gauges

Pin gauges

Optical inspection tools

Job description

Cephas Consultancy Services Private Limited in West Chester, PA, seeks a hands-on Quality Control Manager for precision-machined medical device components. You will lead inspection activities, maintain quality documentation, and support ISO 9001 and ISO 13485 compliance.

You will review jobs, develop inspection plans, perform FAIs, mentor inspectors, and drive CAPA and MRB processes to ensure product conformity and regulatory readiness.