Why QED?

Quiet Clean environment
Employees can wear headphones at their station
Growth Potential
Core hours - 1st Shift 7:00am to 3:30pm

Why you?

Looking to put your experience to good use.
You like to solve problems
You like with working with your hands, and your good with them.
You like having detailed instructions.
You think electronics are interesting.
You want to make a difference in people lives

Then please join us as a Product Quality Inspector!

JOB SUMMARY

We are seeking a detail-oriented and quality-driven Product Quality (PQ) Inspector to join our team. In this role, you will be responsible for ensuring the highest standards of quality and compliance across incoming materials, in-process production, and finished medical devices. You will conduct inspections, functional testing, and evaluations using a variety of measurement techniques, while accurately documenting results in accordance with established quality systems and Good Documentation Practices (GDP).

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.

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