Description
Required Education/Certifications/Skills:
- High School diploma or equivalent required
- Minimum 5 years' experience in medical device Quality Control Inspection
- Ability to lift and work with parts or sub-assemblies weighing up to 50lbs
- Strong computer abilities; web based systems, Microsoft Office, Material and Document Control Software
- Excellent training abilities and skill
- IPC 610 and IPC 620 Certifications (desired)
Qualifications/Responsibilities:
- Ability to read, analyze, and interpret engineering drawings, product specifications, receiving inspection plans, and test procedures.
- Perform visual, dimensional, and functional inspections on consumable products, Laser systems, subassemblies, fixtures, and raw material.
- Understand and inspect mechanical assemblies and electronic circuits.
- Understand and utilize Zero Acceptance Sampling Plans using AQL sampling and 100% inspection.
- Through knowledge and understanding of Geometric Dimensioning and Tolerancing (GD&T) and inspection techniques.
- Proficiency with the utilization and programming of coordinate measuring machine (CMM).
- Utilize and train others to use various measuring equipment to determine component acceptance.
- Perform complex First Article Inspections; gathering data and submitting reports.
- Review DHRs and LHRs for Good Documentation Practices.
- Interface with Engineering, Quality, and Production Teammates to communicate quality standards and address issues in a timely manner.
- Prepare area and participate in internal and external quality audits.
- Accurately train inspectors in Receiving Inspection areas minimizing quality mistakes.
- Control nonconforming material and assist in release of quarantine product; which includes: creating, verifying, and closing nonconforming reports.
- Able to draft and generate SOP changes a using web based documentation system.
- Identify improvement opportunities and give input to procedure and process updates.
- Successfully work in and promote a team oriented environment; reduce work area distractions.
Equipment and Systems Used:
- Micrometers
- Video micrometer
- Pin gauges
- Surface height indicator
- Digital and manual calipers
- Optical comparator
- Video inspection system
- Microscope
- Laser energy meters
- Optical alignment fixtures
- MicroVu CMM (Coordinate Measuring Machine)
- OGP CMM
- Instron pull test equipment
- Digital multi-function meters
- Computer based Learning System
- Agile documentation system
- Oracle Applications