Quality Technician II - Orion

QUALITY TECHNICIAN II - Orion

Actively Hiring – Immediate Openings

Hours: full-time position.

Competitive pay & benefits: paid overtime, health, dental, vision, paid time off, 401k with match… and more!

“Come Build your Career in our Growing, Fast-Paced, Customer-Focused Company that fosters Training & Professional Development!”

WHAT YOU WILL DO:

“Quality & Safety are Top Comar Priorities”

• Perform first piece, daily visual and dimensional analysis of finished product at required intervals 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.
• Approve / reject production start based upon results of first piece inspection.
• Issue gauges to production floor as necessary.
• Communicate information relating to shift with on-coming shift and management.
• Maintain retained samples.
• Read and interpret part prints.
• Work with other team members to ensure all required work is completed each day. 
• Provide training for new team members, as assigned by Lead Quality Inspector. 
• Demonstrate collaborative efforts with operations when addressing nonconformances.
• Escalate issues, as needed, to Lead Quality Inspector.
• Maintain a clean and safe work environment.
• Follow and communicate to others all plant Health, Safety and Quality guidelines and GMP.
• Assist to onboard new Quality Technician I as needed.
• ISO13485 additional position responsibilities: 
  • Provide support and guidance to operations on the floor with respect to ISO 13485 and cGMP requirements.
  • Regularly operate in a cleanroom setting, Support and provide training to personnel on proper gowning and cleanroom behavior.
  • Perform and coordinate environmental monitoring activities for certified clean rooms.
  • Perform DHR review and sign off to ensure records are reviewed and complete prior to release of product. Assist with and lead NCR investigations and root cause analysis. Provide guidance for determination of corrective actions and disposition of material.

Safety and Cleanliness

“We have put in place Covid-19 practices for our employees’ safety”

• 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, masks, hairnets.

WHO WE ARE LOOKING FOR:

“A Comar employee who will represent the customer and be the consumer’s advocate”

Are You…?

• High school or Vo-Tech graduate with 2 years of experience in Quality Control or in a GMP Manufacturing environment
• Working Knowledge of computers and software.
• Working Knowledge of Statistical Process Control (SPC) tools and techniques and Gauge Repeatability and Reproducibility (Gauge R&R)

Preferred:

• 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 or regulated environment and / or a cleanroom environment.
• Experience with environmental monitoring. 
• Knowledge of Regulated Industry CFR Part 820 Quality System Requirements, the ISO family of standards, particularly ISO 13485 and 9001, and others.
• Knowledge of the safety requirements and complexity of working with automated and semi-automated production and inspection systems in a factory environment.

Do You…?

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals with strong ability to write routine reports.
• Ability to work independently and in a team environment. 
• Skilled at learning the use of equipment for dimensional analysis.
• Detail-oriented with the capability of discovering nonconformances in both paperwork and materials.
• Strong basic math skills: add, subtract, multiply, divide, compute rate, ratio, and 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 interact with manufacturing associates in a meaningful way to ensure collaboration and trust.

Do you Enjoy Physical Work where you will…?

• 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. 

If the answer is YES, don’t delay, Apply Today!