Product Quality Inspector II

COMPANY OVERVIEW

Quality Electrodynamics (QED), located in Mayfield Village, OH, is a global developer, manufacturer and supplier of advanced medical equipment electronics. Current products include cutting edge MRI radiofrequency (RF) antennas/coils for diagnostic imaging at the full range of magnetic field strengths. Most of these are FDA Class II noninvasive devices used for obtaining diagnostic images for various human anatomies.

JOB SUMMARY

The Product Quality (PQ) Inspector will perform inspections, checks, tests and sampling procedures for incoming materials, parts and components. Perform in-process and final inspections for partially assembled and/or finished medical devices.  Write product non-conformances.  Review quality records for completeness and accuracy.  

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform inspections of purchased parts, subassemblies, in-process product and finished products according to defined criteria using standard physical, mechanical and/ or electrical measurements
• Accurately and clearly document the results of inspections including quantitative measurements and observations
• Draft or revise inspection documents based on feedback from management and observations of best practices
• Work with Operations and Quality Management to drive continuous improvement of inspection methods and processes and meet departmental objectives
• Perform review of device history records (DHRs) and other documentation for compliance to established procedures and good documentation practices (GDP)
• Write non-conformance reports.  Ensure non-conformances are closed in a timely manner
• Participate in quality audits of the quality management system
• Other tasks as may be assigned by management

QUALIFICATIONS: 
Education and Experience

Required

• High school diploma or GED; or equivalent combination of education and experience
• Minimum of one year experience performing electrical or mechanical QC/QA inspections

Preferred

• Associate’s degree in a technical discipline 
• PCBA inspection experience and/or IPC 610 certification
• Experience with ISO and FDA audits
• Experience with QC/QA medical device inspection or test, especially MRI

Skills and Abilities

Required

• Meticulous attention to detail – absolute must
• Must be self-directed, self-motivated and able to work in a fast-paced team environment
• A genuine belief in continuous improvement and disciplined processes
• Self-starter with ability to multi-task and prioritize work day/projects independently
• Excellent interpersonal and communication skills
• Computer skills including working with word documents, spreadsheets, email and PLM/ERP business applications
• Ability to follow good documentation practices (GDP)s

Preferred

• Understand and interpret mechanical drawings and electrical schematics
• Working knowledge of printed circuit board (PCB) inspection standards (IPC-A-600)
• Technical writing skills
• Root cause investigation skills and an understanding of various investigative methods (5 Whys, Fault Tree, etc.)
• Risk evaluation skills (PFMEA, Fault Tree) and rework adverse effect assessment

Physical Requirements

• Be able to lift 25 lbs.