Quality Technician: ISO 13485 Inspector & Containment

Comar; West Bend (WI); On-site; USD 42,000 - 54,000; Full time

Job summary

Comar in West Bend, WI is seeking a Quality Technician to support daily manufacturing by performing routine visual and dimensional inspections to ensure products meet quality and regulatory requirements.

You will conduct first piece and in-process checks, document results, identify non-conformances, and assist containment activities while supporting ISO 13485 and cGMP compliance on the production floor.

Qualifications

• High school or Vo-Tech graduate with 0-1 years’ experience in Quality Control or in a GMP Manufacturing environment.
• Proficient in understanding and learning computers and software.
• Understanding of Statistical Process Control (SPC) tools and techniques and Repeatability and Reproducibility (Gauge R&R).

Responsibilities

• Perform first piece and daily visual and dimensional analysis of finished product at required intervals as specified on the inspection plans.
• Perform first article inspection and evaluation.
• Perform floor audits of paperwork, materials, finished product, and control plan at required intervals as specified on the inspection plans.
• Control of Non-Conforming Product - Perform inspection of non-conforming product, Initiate containment activities, execute control of non-conforming product procedures and documentation of results.
• Follow and communicate to others all plant Health, Safety and Quality guidelines and GMP.
• ISO13485 additional position responsibilities: Provide support and guidance to operations on the floor with respect to ISO 13485 and cGMP requirements.

Skills

SPC

Gauge R&R

Computer literacy

Education

Bachelor’s degree in science/engineering

Tools

Inspection software

MS Excel

Job description

Comar in West Bend, WI is seeking a Quality Technician to support daily manufacturing by performing routine visual and dimensional inspections to ensure products meet quality and regulatory requirements.

You will conduct first piece and in-process checks, document results, identify non-conformances, and assist containment activities while supporting ISO 13485 and cGMP compliance on the production floor.