Quality Inspector

Regulatory Jobs; Mayfield (OH); On-site; USD 42,000 - 54,000; Full time

Benefits offered by this job

Overtime available

Job summary

Regulatory Jobs is seeking a detail-oriented Product Quality Inspector to ensure the highest standards across incoming materials, in-process production, and finished medical devices. You will perform inspections, functional testing, and evaluations using measurement techniques, and document results in line with GDP.

Essential duties include inspecting parts and assemblies to defined criteria, drafting or revising inspection documents, reviewing device history records for GDP compliance, and

Qualifications

• High school diploma or GED required or equivalent experience.
• Minimum of one year experience performing electrical or mechanical QC/QA inspections.
• Prefer associate’s degree in a technical discipline.
• IPC 610 certification and PCB inspection experience preferred.
• Experience with ISO and FDA audits preferred.
• Experience inspecting QC/QA medical devices, MRI preferred.

Responsibilities

• Perform inspections of purchased parts, subassemblies, in-process product and finished products using standard measurements.
• Document inspection results with quantitative measurements and observations.
• Draft or revise inspection documents based on feedback and best practices.
• Collaborate with Operations and Quality Management to improve inspection methods.
• Review device history records (DHRs) for GDP compliance.
• Write non-conformance reports and ensure timely closure.
• Participate in quality audits of the QMS.
• Other tasks as assigned by management.

Skills

Attention to detail

Self-motivated

Continuous improvement

Multitasking

Interpersonal skills

PC/ERP tools

GDP compliance

Education

High school diploma or GED

Associate’s degree (technical)

Tools

PCBA inspection

IPC 610 certification

ISO/FDA audits

Medical device QC inspection/MRI

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.

7:00am to 3:30 pm
OT available