Quality Technician I - Night Shift

Comar•Woodville, WI

1d•Onsite

About The Position

The Quality Technician I is responsible for performing first piece and daily visual and dimensional analysis of finished product at required intervals as specified on the inspection plans. This role also involves performing first article inspection and evaluation, as well as floor audits of paperwork, materials, finished product, and control plans. The technician will manage non-conforming product by inspecting it, initiating containment activities, executing control procedures, and documenting results. Collaboration with team members to ensure daily work completion and escalating issues to the Lead Quality Inspector are key aspects of the role. The technician must be able to effectively operate equipment, maintain a clean and safe work environment, and follow all plant Health, Safety, and Quality guidelines and GMP. For ISO13485, additional responsibilities include providing support and guidance to operations on the floor regarding ISO 13485 and cGMP requirements. Other duties as assigned.

Requirements

High school or Vo-Tech graduate
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).
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to work independently and in a team environment.
Skilled at learning the use of equipment for dimensional analysis.
Detail-oriented/capability of discovering nonconformances in both paperwork and materials.
Ability to apply basic math skills: add, subtract, multiply, divide. Compute rate, ratio, percent.
Ability to carry out instructions provided in written, oral, or visual / diagram format.
Ability to communicate their job related functions with other employees, cross-department, with customers and auditors as needed.
Ability to write routine reports.
Ability to interact with manufacturing associates in a meaningful way to ensure collaboration and trust.
Effectively communicate with supervisor.
The ability to read, write, and comprehend information provided.
Stand for most of the work shift.
Use hands and fingers to handle or feel; reach with hands and arms; stoop, crouch, bend, twist, and only occasionally sit.
Lift and/or move up to 10 pounds. Heavier amounts can be moved with assistance of equipment.

Nice To Haves

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.
Knowledge of and/or previous experience in a manufacturing environment is a plus!

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: Inspect non-conforming product, initiate containment activities, execute control of non-conforming product procedures and documentation of results.
Work together with other team members to ensure all required work is completed each day.
Escalate issues, as needed, to Lead Quality Inspector.
Effectively operate equipment as required.
Maintain a clean and safe work environment.
Follow and communicate to others all plant Health, Safety and Quality guidelines and GMP.
Provide support and guidance to operations on the floor with respect to ISO 13485 and cGMP requirements.
Other duties as assigned.
Adhere to safety policies.
Maintain a clean and safe work area and report any unsafe conditions to supervisor.
Wear company issued personal protective equipment (PPE) such as uniforms, gloves, hairnets.