Product Quality Inspector

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

• Associates 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.

Fenagh Engineering & Testing