Quality Technician - 2nd Shift

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

As a Quality Technician, you will support daily manufacturing operations by performing routine visual and dimensional inspections to ensure products meet quality and regulatory requirements. You’ll be responsible for first piece and in process checks, documenting results, identifying non conformances, and supporting effective containment activities. This role plays an important part in maintaining product quality, supporting compliance with ISO 13485 and cGMP, and partnering with the production team to keep operations running smoothly.

What You’ll Do

• 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.

Required 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).

Preferred Qualifications

• Bachelor’s degree in science, technology, engineering or significant applicable experience, training, and certifications.
• Experience working in medical device, pharmaceutical, or food manufacturing environments.
• Experience with visual inspection standards and processes.
• Experience working in an ISO, cleanroom, or regulated environment.

This position is based in West Bend, WI, and relocation assistance is not available.

Equal Opportunity Employer
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