Quality Control Inspector I (2nd shift)

About the role

The Quality Control Inspector I will handle all aspects of inspection (receiving, in-process, and final) and provide QSR support for other QA activities such as calibration, environmental monitoring, product testing, and label control.

Responsibilities

• Receiving Inspection:
  • Inspect components following procedures, specifications, and drawings.
  • Use standard metrology equipment, including optical comparator, height gauge, master height gauge, CMM, Vision Metrology System (VMS, e.g., Smartscope), calipers, micrometers, surface table, gauge blocks, pin gauges, dial indicators, durometer, measuring microscope, hardness testers, pull force testers, and surface roughness testers.
  • Read engineering drawings and interpret geometric dimensioning and tolerancing.
  • Review associated paperwork, complete inspection records using good documentation practices, and release components.
  • Program the Smartscope to run automatic routines for multiple part inspections (Level 2 and higher).
  • Write clear and concise procedures for inspection of components and machined tubing (Level 2 and higher).
  • Handle and process extremely small components without damaging them.
• In-Process Inspection:
  • Perform line clearance for operations activities.
  • Inspect and release labeling.
  • Review device history records for lot release, ensuring all quality records meet good documentation practices in accordance with internal procedures.
  • Perform inspections on components and assemblies in manufacturing.
• Final Inspection:
  • Review device history records for lot release, ensuring all quality records meet good documentation practices.
  • Perform final inspection on finished goods.
  • Inspect finished goods for proper labels, packaging, tamper seals, and product in accordance with procedures.
  • Coordinate final inspection activities with outside vendors (e.g., LAL, peel testing).
  • Perform in-house peel testing on sealed packages.
  • Maintain sample retain area.
• Other Duties:
  • Work with engineering in the design of high-quality inspection/metrology fixtures.
  • Support equipment and process validation activities by inspecting process outputs.
  • Conduct periodic compliance audits of manufacturing operations and procedures for cGMP compliance.
  • Ensure daily quality records and company practices comply with internal procedures and regulations.
  • Coordinate monthly environmental monitoring of cleanrooms.
  • Coordinate quarterly dose audits.

Requirements

• High School Diploma required.
• 0-2 years of industry experience.

Skills

• Medical device experience and working knowledge of QSR required.
• Experience working in a cleanroom and/or performing in-process assembly and manufacturing verification inspections desirable.
• Strong attention to detail and accuracy.
• Excellent documentation skills.
• Team player with good written and oral communication skills.
• Organized and able to coordinate activities with outside vendors.