Own and maintain the site ISO 13485 Quality Management System
Ensure compliance with ISO 13485, FDA 21 CFR Part 820 (as applicable), Customer-specific quality requirements
Develop, implement, and control quality policies, procedures, work instructions, and records
Manage document control and record retention systems
Lead management reviews and track quality KPIs
Serve as primary point of contact for ISO certification audits, Customer audits, and Regulatory inspections
Plan, conduct, and document internal audits
Drive corrective actions resulting from audits to timely and effective closure
Oversee Nonconformance (NCR) and CAPA processes
Lead root cause analysis using structured problem-solving tools (5 Whys, Fishbone, etc.)
Ensure corrective and preventive actions are effective and sustained
Lead inspection and measurement activities including Incoming, in-process, and final inspection
Ensure appropriate use and calibration of equipment
Maintain calibration program for all measuring and test equipment
Ensure risk-based thinking is embedded into quality processes
Approve and monitor suppliers and special process vendors and conduct supplier audits as required
Partner with Operations, Engineering, and Production to improve process capability and yield

Bachelor’s degree in Engineering, Quality, Manufacturing, or related field (or equivalent experience)
5+ years of quality leadership experience in a CNC machining or manufacturing environment
Hands-on experience with ISO 13485 (certified environment strongly preferred)
Experience supporting medical device customers highly preferred
Strong knowledge of: ISO 13485, FDA QSR (21 CFR 820), GD&T, Statistical methods and SPC
Experience with CMM programming and metrology systems
Proficiency with root cause analysis and CAPA methodologies
Strong documentation and technical writing skills

Quality Manager

Key skills