Quality Technician III at Comar in West Bend, Wisconsin

Job Description:

QUALITY TECHNICIAN III




2nd shift 3:45 pm to 12:15 am




Actively Hiring – Immediate Openings




Hours: full-time position.



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



WHAT YOU WILL DO:




“Quality & Safety are Top Comar Priorities”

• Perform Quality Inspector duties and fill-in as necessary in event of absence or shortage of staff, including: First Article, Incoming, In-Process, and Final Release Inspection/Testing; Control of Non-Conforming Product; Control Plan Audit; Verification of proper testing and reactions to results.
• Calibrate equipment and coordinate service with calibration suppliers; Maintain Calibration Records.
• Set up and maintain SPC (Statistical Process Control) data collection system.
• Manage Quality Documents Control as applicable.
• Work together 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 non-conformances.
• Escalate issues, as needed, to Quality Supervisor or Cell Leaders.
• 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.
• Assist to onboard new Quality Technician I & II 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.
  • Schedule and organize daily tasks of other Quality Inspectors. Coordinate overtime work, as needed. Perform/oversee training. Act as the Quality point-of-contact for manufacturing operations. Act as informal lead/backup to supervisor. Escalate issues to Quality Supervisor as needed.
• Other duties as assigned.

Additional Responsibilities & Skills for our SQF Certified Sites:

• Have a basic understanding of the cGMPs and Good Hygiene Personnel Practices
• Notify SQF Practitioner and/or Supervisor of any repairs or adjustments that are required.
• Perform Basic Sanitation Functions
• Perform all duties necessary to meet Company, and or Regulatory Requirements / standards as prioritized by the Company, HACCP, and SQF.
• Notify SQF Practitioner/Quality Manager or any other Management personnel of ANY Food Safety or Quality issues.
• Identify problems relating to Food Safety and the Quality of the raw material, processes, quality system, or safety system, by performing Production/Quality Checks as assigned.
• Ability to initiate action to prevent the occurrence of nonconformities relating to Food Safety and the Quality of the product, processes, quality system, or safety system. Be able to execute and follow the HOLD SOP.
• Controls further processing or delivery of nonconforming product in terms of Food Safety and Quality issues until the deficiency or unsatisfactory condition has been corrected.
• Employee follows all Food Fraud/food Defense Policies while on company property.
• Thorough understanding of all Company policies, including GMP’s and safety policies, HACCP & SQF.

Safety and Cleanliness

• 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.

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 4 years’ experience in Quality Control or in a GMP Manufacturing environment.
• Experience in ISO certified or regulated environment.
• Proficiency with computers and software.
• Proficiency with Statistical Process Control (SPC) tools and techniques.
• Proficiency with 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 or food manufacturing environments.
• Experience with visual inspection standards and processes.
• Experience working in an ISO or regulated environment and a clean room 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.
• Ability to work independently and in a team environment.
• Skilled at learning the use of equipment for dimensional analysis.
• Detail-oriented/capability of discovering non-conformances 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.
• Ability to troubleshoot and diagnose measurement system errors.
• Ability author work instructions for quality related materials and processes (e.g. SPC, Calibration, Gauge R&R and Testing).
• Ability to interpret product drawings and specifications.
• Ability to speak effectively before groups of customers or employees.
• Effectively communicate with supervisor.
• The ability to read, write, and comprehend information provided.
• Displays strong leadership and organizational skills.

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 YES, don’t delay, Apply Today! Apply Now