Product Quality Inspector

Job Description

Job Description

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.