Quality Technician I

Comar•Buena, NJ

61d•Onsite

About The Position

The Quality Technician I plays a crucial role in ensuring product quality and safety, aligning with Comar's top priorities. This position involves performing detailed analyses of finished products, conducting floor audits, and managing non-conforming products. The role also requires collaboration with team members, adherence to health, safety, and quality guidelines, and providing support for ISO 13485 and cGMP requirements. The ideal candidate will act as a consumer advocate, representing the customer's interests.

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

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.
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: Perform inspection of 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.
Be able to 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.