Quality Manager, Medical Devices (ISO 13485 & FDA)

Technimark LLC; Asheboro (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

Technimark LLC is seeking an experienced Quality Manager to lead the QMS for our Medical Device Manufacturing operations in Asheboro, North Carolina. You will ensure ISO 13485, FDA 21 CFR Part 820, and customer requirements are met while driving continuous improvement and operational excellence.

Reporting to the Senior Quality Manager, you will mentor Quality Engineers and Supervisors, manage CAPA and audits, lead validation activities, and build a culture of accountability and quality across

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or related field.
• 5-10 years of quality experience with 3+ years in a management role.
• 5+ years of experience in Medical Device Manufacturing.
• Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
• Experience leading Quality Management Systems in a regulated manufacturing environment.
• Experience with validation planning, protocol development, execution, and reporting.

Responsibilities

• Ensure the Quality Management System remains effective, compliant, and continuously improving.
• Report key quality metrics to leadership and drive improvement initiatives.
• Lead Master Validation Plan and validation strategy.
• Lead new process validations and maintain validated processes.
• Oversee CAPA system and drive root cause investigations.
• Administer Customer Complaint Management System and close out actions.
• Drive trend analysis and lean/culture of continuous improvement.

Skills

QA leadership

ISO 13485

FDA 21 CFR 820

CAPA system

DOE

SPC

Metrology

Calibration

Lean Manufacturing

Six Sigma

Communication

Education

Bachelor's Degree in Engineering

Master's Degree preferred

Tools

Validation protocols

Process validation

Audit management

Job description

Technimark LLC is seeking an experienced Quality Manager to lead the QMS for our Medical Device Manufacturing operations in Asheboro, North Carolina. You will ensure ISO 13485, FDA 21 CFR Part 820, and customer requirements are met while driving continuous improvement and operational excellence.

Reporting to the Senior Quality Manager, you will mentor Quality Engineers and Supervisors, manage CAPA and audits, lead validation activities, and build a culture of accountability and quality across