Responsibilities:

• Perform incoming inspection activities, including receiving parts, conducting visual and mechanical inspections, documenting nonconforming material, updating ERP records, and supporting material disposition decisions.
• Complete First Article Inspection (FAI) activities.
• Perform final product verification and audit release activities.
• Participate in third-party compliance audits, customer audits, process audits, and internal audits.
• Support the calibration program by collecting, organizing, calibrating, and returning equipment, while maintaining calibration records and databases.
• Assist Engineering with Engineering Sample Inspection Reports.
• Support the review of customer returns and related quality documentation.
• Collaborate with Production, Engineering, Manufacturing, and suppliers to identify, investigate, and resolve product quality issues.
• Maintain accurate quality records and documentation.
• Support Quality Management System initiatives and continuous improvement efforts.
• Perform additional duties as assigned.

Required Qualifications:

• Associate degree (AAS) in a technical discipline and at least 5 years of experience in a manufacturing environment, preferably in quality inspection.
• Ability to work independently and manage responsibilities with minimal supervision.
• Familiarity with validation and calibration requirements within a regulated manufacturing environment.
• Proficiency with Microsoft Office applications and quality-related systems and databases.
• Ability to read and interpret engineering drawings and specifications.
• Experience using inspection and measurement equipment, including:
  • Coordinate Measuring Machines (CMM)
  • Optical comparators
  • Calipers
  • Micrometers
  • Height gauges
  • Multimeters
  • Oscilloscopes
• Strong written and verbal communication skills.
• Ability to sit, stand, and move throughout a manufacturing facility as needed.
• Ability to use a microscope for extended periods of time.

Preferred Qualifications:

• Experience in a medical device manufacturing environment.
• Experience supporting quality audits and quality management systems.
• Experience working with nonconforming material processes, calibration programs, and product verification activities.