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Quality Compliance Coordinator

Posted on July 23, 2025

  • Kenosha, United States of America
  • 21.0 - 28.0 USD (hourly)
  • Full Time

Quality Compliance Coordinator

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Job Summary
We are seeking a dedicated and detail-oriented Compliance Coordinator/Specialist to join our team. The ideal candidate will play a crucial role in ensuring that our operations adhere to regulatory standards and internal policies. This position requires a strong understanding of ISO 9001, FDA regulations, quality systems, and compliance frameworks such as GMP. The Compliance Coordinator will work collaboratively across departments to promote a culture of quality management and assurance.

Responsibilities

  • Collecting, organizing, monitoring and distributing information related to quality and process improvement functions.
  • Assist in internal (GMP, NSF, FDA, ISO), offsite, regulatory and managing timely resolutions of issues identified within the audits, subsequent implementation of correct actions (8D-CAPA), tracking and follow up to ensure compliance.
  • Maintain and manage submit REACH, RoHs, Prop 65, PFAS.
  • Monitors internal KPI quality metric actions to meet company goals.
  • Internal audits of the GQMS at Kenosha.
  • Assist in Engineer changes and deviations.
  • Supplier audits
  • Audit the Quick inspection data on a regular basis for compliance. This is reviewing inspection records in Quick Inspection.
  • Coordinate with supply chain and production teams to support quality requirements.
  • Prepare and present reports on quality activities to management.
  • All other duties as assigned

Non-Essential Job Duties:

  • Monitor material receiving and documentation control activities
  • Assist with new project launches
  • Track all quality holds, prepare deviation paperwork, and other documents for Quality Manager
  • Train and support staff in understanding quality documentation.
  • Assist in the development and implementation of quality assurance procedures and policies

Qualifications:

  • BA/BS in related field is preferred, or work experience equivalent.
  • 2+ yrs within a manufacturing environment
  • Bilingual (Spanish) is a plus.
  • Passion and enthusiasm for customer service and solving customer problems are essential.
  • Proficiency in planning, organizing, and multi-task management.
  • Strong communication skills including verbal, writing, and listening skills willing to work cooperatively in a team environment. Competent with computers.
  • Experience with plastic injection molding and tooling, education or training is preferred.
  • Must be high energy and able to prioritize and multitask in a fast paced and rapidly changing environment.
  • Resourceful and problem-solving abilities are required.
  • Self-motivated.

SKILL KNOWLEDGE & ABILITY

  • Experience with FDA, ISO and other regulatory requirements is preferred.
  • Experience with ISO 9001:2015
  • Must have the ability to read, write and understand written and verbal instruction.
  • Able to complete reporting requirements as assigned.
  • Computer skills.
  • Good attendance and punctuality is essential.

PHYSICAL REQUIREMENTS:

  • Ability to work in a fast-paced environment
  • Reaching, bending and squatting multiple times per day.
  • Ability to pull or push 200lbs with use of pallet jack.
  • Ability to stand for long periods of time.
  • Ability to lift up to 75lbs.
  • Ability to work in an environment that is not climate controlled.
  • Able to use hand and power tools that require grasping throughout the shift.
  • Must be comfortable climbing ladders, machinery and using scissor lift to reach heights to work on equipment.
  • Must be able to work over 8 hours, if needed and weekends, if necessary.

Training

· All required QSP’s

Job Type: Full-time

Pay: $21.63 - $28.00 per hour

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Referral program
  • Tuition reimbursement
  • Vision insurance

People with a criminal record are encouraged to apply

Experience:

  • Quality Compliance: 2 years (Required)

Ability to Commute:

  • Kenosha, WI 53144 (Preferred)

Ability to Relocate:

  • Kenosha, WI 53144: Relocate before starting work (Preferred)

Work Location: In person


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