Quality Control Manager Machine Parts

Job Role: Quality Control Manager Machine Parts

Location: West Chester, PA

Job Description:

Position Summary:

Leads quality control activities for precision-machined medical device components. Responsible for inspection planning, First Article and in-process inspections, nonconformance management, ISO compliance, ERP tracking, and mentoring quality staff across machining cells and shifts.

Core Responsibilities

• Develop and oversee inspection plans across machining cells
• Perform and review First Article Inspections and in-process inspections
• Lead nonconformance investigations, MRBs, and corrective actions
• Maintain ISO 9001 and ISO 13485 compliance
• Track quality data and documentation within ERP systems
• Train and mentor inspectors and machinists on quality standards
• Support internal audits and calibration programs

Must-Have Qualifications

• 5+ years quality experience in precision machining environment
• Strong blueprint reading and GD&T knowledge
• Experience performing FAIs and in-process inspections
• Experience managing nonconformance and corrective actions
• Familiarity with ISO 9001 and ISO 13485 systems
• Ability to mentor and train quality personnel

Preferred Qualifications

• CNC or Swiss machining background
• Experience supporting audits and calibration programs
• ERP system experience in manufacturing setting
• Engineering degree or equivalent hands-on experience

Work Environment & Process

• Precision, climate-controlled medical device facility
• Regulated and quality-driven environment
• Uniforms and safety equipment provided at no cost
• Overtime based on production demands
• Interview process includes virtual interviews, onsite visits, and skills assessment