Job Description
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. Quality Electrodynamics
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