Top 90 Quality manager Jobs in Kenosha Wi

Quality Manager - Medical Device/ ISO 13485
Vonco Products LLC —Trevor, WI
- $95,000 - $125,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Engineering
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Quality Control Manager
Zing Recruiting —Libertyville, IL
- $70,000 - $85,000 a year
- Monday to Friday
- Laboratory experience
- Mid-level
- High school diploma or GED
- Relocation assistance
- Health insurance
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9d
QC Manager (CQC System Manager) - Government Construction
The Povolny Group, Inc. —North Chicago, IL
- Full-time
- Construction site
- 5 years
- Computer literacy
- Health savings account
- Paid holidays
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Quality Assurance Team Lead
Uline —Pleasant Prairie, WI
- Full-time
- Management
- Computer Science
- Pass drug screening
- Paid holidays
- Health insurance
7d
Corporate Process Quality Manager (HIGH MIX LOW VOLUME)
ilocatum —Spring Grove, IL
- $100,000 - $120,000 a year
- Full-time
- 7 years
- Engineering
- Senior level
- Employee stock ownership plan
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Site Quality Manager
Jabil Circuit —Gurnee, IL
- $103,100 - $185,600 a year
- Full-time
- Mid-level
- Bachelor's degree
- Mentoring
- Commuter assistance
- Paid parental leave
Quality & Safety Manager
L&M Corrugated Container —Pleasant Prairie, WI
- Full-time
- Mentoring
- Manufacturing
- Senior level
- Profit sharing
- Paid holidays
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Quality & Compliance Manager onsite in Pleasant Prairie, WI- Life Sciences/ Pharmaceutical
CBRE —Kenosha, WI
- $120,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Mid-level
Quality Manager
Rehrig Pacific Company —Pleasant Prairie, WI
- Full-time
- 5 years
- Engineering
- Senior level
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8d
Quality Manager
MPE-Inc —Sturtevant, WI
- Full-time
- Engineering
- Office
- Ability to lift 50 pounds
- Health savings account
- Paid holidays
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Quality Supervisor
Jabil Circuit —Gurnee, IL
- $81,400 - $146,500 a year
- Full-time
- 5 years
- Basic math
- English
- Commuter assistance
- Paid parental leave
Quality Manager
DeltaHawk Engines, Inc. —Racine, WI
- 7 years
- Office
- Business Administration
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AQR Quality Program, Manager
Abbott Laboratories —Abbott Park, IL
- $129,300 - $258,700 a year
- Full-time
- Management
- Laboratory experience
- Supervising experience
- Health insurance
- Tuition reimbursement
Quality Control Manager
Gilbane —Kenosha, WI
- Microsoft Word
- Microsoft Excel
- Bachelor of Science
- Profit sharing
- Health insurance
Senior Manager, Quality
Steris —Libertyville, IL
- $120,000 - $150,000 a year
- Full-time
- Word processing
- Manufacturing
- Senior level
- Paid holidays
- Disability insurance
Quality Control Manager
Gilbane Building Company —Kenosha, WI
- Full-time
- Microsoft Word
- Microsoft Excel
- Bachelor of Science
- Profit sharing
- Health insurance
Quality Assurance Manager
Rapido Talent —Spring Grove, IL
- $80,000 - $150,000 a year
- Full-time
- Management
- Manufacturing
- Senior level
- Relocation assistance
- Employee stock ownership plan
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Manager, Quality Manager - CAPA
Abbott Laboratories —Abbott Park, IL
- $129,300 - $258,700 a year
- Full-time
- Supervising experience
- Training & development
- Senior level
- Health insurance
- Tuition reimbursement
Director Quality and Process Improvement
Goodwill Greater Milwaukee & Chicago —Great Lakes, IL
- $107,150 - $160,725 a year
- Full-time
- 5 years
- Bachelor's degree
- Mentoring
- Disability insurance
- Health insurance
Quick Apply
Process Quality Manager
Rapido Talent —Spring Grove, IL
- $80,000 - $150,000 a year
- Full-time
- Mid-level
- Relocation assistance
- Employee stock ownership plan
Quick Apply

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quality manager jobs near kenosha wi

Quality Manager - Medical Device/ ISO 13485

Vonco Products LLC -
Trevor, WI

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Job Details

Full-time
$95,000 - $125,000 a year

Qualifications

Incident investigation techniques for hazard identification
Defect resolution root cause analysis
Production deviation management
Quality control preventive actions
Corrective and preventive actions (CAPA)
ISO certification audits
Quality control audit
Change management
Vendor compliance audits
Supplier audits
Production validation processes
Medical device manufacturing facility experience
Internal compliance assessments
Biomedical regulatory compliance
Audit support
Failure analysis

Full Job Description

Description:

Quality Manager | ISO 13485 Medical Device Manufacturing

We are seeking a hands-on Quality Manager who can lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. This individual will serve as the site quality leader, partnering closely with Operations, Engineering, Supply Chain, and Customer Service to ensure compliance, drive continuous improvement, and maintain customer confidence.

The ideal candidate is a proactive quality leader with experience in medical devices, healthcare packaging, or other regulated manufacturing environments. They are comfortable balancing strategic quality system oversight with day-to-day operational support and can effectively influence cross-functional teams.

Basic Purpose and Function: The Quality Manager is responsible for developing, implementing, maintaining, and continuously improving the organization's Quality Management System (QMS) in accordance with ISO 13485, applicable regulatory requirements, customer requirements, and company objectives.

This position serves as the site's management representative for the Quality Management System. It ensures that product realization activities, risk management processes, supplier controls, CAPA activities, and post-market quality processes effectively support the manufacture of safe and effective medical devices.

The Quality Manager partners closely with Operations, Engineering, Supply Chain, and Customer Service teams to ensure compliance while driving a culture of quality and continuous improvement.

Job Responsibilities:

Quality Management System (QMS)

Manage and maintain the ISO 13485 Quality Management System.
Ensure compliance with all applicable regulatory and customer requirements.
Oversee document control and record retention processes.
Coordinate Management Review activities and present quality system performance metrics.
Ensure quality objectives are established, monitored, and achieved.
Maintain inspection readiness and audit preparedness.

CAPA and Nonconformance Management

Lead the Corrective and Preventive Action (CAPA) program.
Ensure timely investigation and closure of quality issues.
Facilitate root cause investigations.
Monitor effectiveness of corrective actions.
Manage nonconforming product processes and disposition activities.

Risk Management

Ensure risk management activities comply with ISO 14971 requirements.
Participate in risk assessments associated with products, processes, equipment, and suppliers.
Support implementation of risk controls and verification of effectiveness.
Ensure risk management files remain current and complete.

Validation and Quality Engineering Support

Review and approve validation protocols and reports.
Support process improvement and process capability initiatives.
Ensure manufacturing changes are properly evaluated and validated.

Internal Audits and Regulatory Inspections

Manage the internal audit program.
Coordinate external audits, customer audits, certification audits, and regulatory inspections.
Track audit findings through closure.

Supplier Quality Management

Ensure supplier qualifications and monitoring programs meet ISO 13485 requirements.
Manage supplier audits and supplier performance reviews.
Oversee supplier corrective action requests (SCARs).
Support supplier risk assessments and change management.

Customer Quality and Complaint Handling

Manage customer complaint investigations.
Ensure complaint-handling processes meet applicable regulatory requirements.
Analyze customer quality trends and implement improvement actions.
Serve as primary escalation point for customer quality issues.

Training and Quality Culture

Ensure employee training programs meet regulatory and quality requirements.
Verify personnel competency for quality-critical tasks.
Promote quality awareness throughout the organization.
Support continuous improvement initiatives across all departments.

Leadership Responsibilities

Lead and develop Quality Specialists, Technicians, Auditors, and Inspectors.
Establish departmental goals and objectives.
Manage department resources.
Provide quality guidance to Operations, Engineering, and Customer Service.

Success Measures

Successful maintenance of ISO 13485 certification
Timely closure and effectiveness of CAPAs
Reduction in customer complaints and internal quality issues
Successful completion of internal, customer, and certification audits
Supplier quality performance improvements
On-time completion of Management Reviews and Quality Objectives

Requirements:

Required Background

Bachelor’s degree in engineering, Quality, Manufacturing, Life Sciences, or related field.
5+ years of progressive quality experience in a regulated manufacturing environment.
3+ years working with ISO 13485 Quality Management Systems.
Experience leading internal, customer, and certification audits.
Strong knowledge of CAPA, nonconformance management, change control, complaint handling, and supplier quality.
Experience in FDA-regulated manufacturing is highly preferred.

Key Characteristics

Strong leadership presence with the ability to coach and develop quality personnel.
Highly organized and detail-oriented.
Effective communicator who can build credibility across all levels of the organization.
Skilled problem solver with root cause analysis experience.
Comfortable making risk-based decisions in a regulated environment.
Able to balance compliance requirements with operational realities.

Technical Expertise: demonstrated experience with:

ISO 13485
CAPA systems
Internal auditing
Risk management (ISO 14971 preferred)
Supplier qualification and supplier corrective actions
Validation activities (IQ/OQ/PQ)
Complaint investigations
Document control and change management

Physical Requirements

Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing, and repetitive motions.
This position frequently requires the use of hands to handle or feel objects, tools, or controls, and to reach with hands and arms.
The associate must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus.

PI286423134

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Refine Your Search

quality manager jobs in kenosha wi

Quality Manager - Medical Device/ ISO 13485

Quality Control Manager

QC Manager (CQC System Manager) - Government Construction

Quality Assurance Team Lead

Corporate Process Quality Manager (HIGH MIX LOW VOLUME)

Site Quality Manager

Quality & Safety Manager

Quality & Compliance Manager onsite in Pleasant Prairie, WI- Life Sciences/ Pharmaceutical

Quality Manager

Quality Manager

Quality Supervisor

Quality Manager

AQR Quality Program, Manager

Quality Control Manager

Senior Manager, Quality

Quality Control Manager

Quality Assurance Manager

Manager, Quality Manager - CAPA

Director Quality and Process Improvement

Process Quality Manager

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