Quality Compliance Coordinator

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: $45,000.00 - $55,000.00 per year

Benefits:

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

Schedule:

• 8 hour shift
• Monday to Friday

People with a criminal record are encouraged to apply

Experience:

• ISO 9001: 1 year (Required)

Ability to Commute:

• Kenosha, WI 53144 (Preferred)

Ability to Relocate:

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

Work Location: In person

Salary : $45,000 - $55,000