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Quality Manager Medical Device Jobs in Wisconsin

Kellton Tech

Medical Device Quality Inspector

Madison, WI · On-site

$30/hr

Medical Device Quality Inspector Location: Madison, WI (Onsite) Pay Rate: $30/hr. on W2 Job Summary ... Familiarity with ISO 13485 or ISO 9001 quality management systems. * Prior experience with material ...

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

This role oversees CAPA, Change Management, investigations, deviations, Quality Management Reviews ... medical device experience preferred) Skills & Competencies: * Strong communication, coaching ...

Kellton Tech

Medical Device Quality Inspector

Madison, WI · On-site

$30/hr

Medical Device Quality Inspector Location: Madison, WI (Onsite) Pay Rate: $30/hr (W2) Job Summary ... Reports to the Quality Control Manager. * Interfaces primarily with manufacturing, engineering, and ...

Kellton Tech

Medical Device Assembler

Madison, WI · On-site

$23 - $24/hr

Ensure work is completed in compliance with company quality system and medical device regulations. Essential Functions Assemble and test finished and semi-finished medical devices per established ...

Kellton Tech

Medical Device Quality Inspector

Madison, WI · On-site

$25 - $30/hr

Medical Device Quality Inspector Location: Madison, WI (Onsite) Pay Rate: $25-30/hr. on W2 **Opportunity to earn overtime pay** The Medical Device Quality Inspection group is responsible for assuring ...

Kimberlyclark

Quality Manager

Neenah, WI

Background in managing Medical Device Quality Management Systems, leadership skills in building ... quality talent throughout a manufacturing facility and have a strong track record of meeting ...

Kimberly-Clark

Quality Manager

Neenah, WI

Background in managing Medical Device Quality Management Systems, leadership skills in building ... quality talent throughout a manufacturing facility and have a strong track record of meeting ...

Kimberly-Clark

Quality Manager

Neenah, WI · On-site

Background in managing Medical Device Quality Management Systems, leadership skills in building ... quality talent throughout a manufacturing facility and have a strong track record of meeting ...

Kimberly-Clark Corporation

Quality Manager

Neenah, WI · On-site

Background in managing Medical Device Quality Management Systems, leadership skills in building ... quality talent throughout a manufacturing facility and have a strong track record of meeting ...

Kimberly-Clark Corporation

Quality Manager

Neenah, WI · On-site

Background in managing Medical Device Quality Management Systems, leadership skills in building ... quality talent throughout a manufacturing facility and have a strong track record of meeting ...

Equiliem

Medical Device Technician

Madison, WI · On-site

$32 - $38/hr

Medical Device Technician Madison, WI Pay: $32.00 - $38.00 per hour 26-05847 Job Summary The ... and quality expectations. * Excellent attention to detail and accuracy. * Ability to manage ...

HonorVet Technologies

Medical Device Technician

Madison, WI · On-site

$38K - $48K/yr

Ensure work is completed in compliance with company quality system and medical device regulations. Essential Functions * Assemble, test, and repair work per established work instructions, policies ...

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All JobsQuality Medical Device JobsQuality Manager Medical Device JobsQuality Manager Medical Device Jobs in Wisconsin

Quality Manager Medical Device information

See Wisconsin salary details

$24.2K

$87K

$159.5K

How much do quality manager medical device jobs pay per year?

As of Aug 21, 2026, the average yearly pay for quality manager medical device in Wisconsin is $86,965.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,400.00 and $137,300.00 per year, depending on experience, location, and employer.

What does a quality manager do in the medical device industry?

A Quality Manager in the medical device industry is responsible for ensuring that products meet all regulatory requirements and quality standards throughout their lifecycle. They develop, implement, and monitor quality management systems, oversee internal and external audits, and work closely with manufacturing, engineering, and regulatory teams to maintain compliance with standards such as ISO 13485 and FDA regulations. Their role is critical to ensuring patient safety and product efficacy by preventing defects and ensuring consistent quality.

What are the key skills and qualifications needed to thrive as a quality manager in the medical device industry?

To thrive as a Quality Manager in the Medical Device industry, you need a solid background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and process improvement, often supported by a relevant degree in engineering or life sciences. Familiarity with quality management systems (QMS), risk management tools (like FMEA), and certifications such as ASQ Certified Quality Auditor (CQA) or Six Sigma are typically required. Strong leadership, attention to detail, and effective communication are vital soft skills for managing teams and ensuring cross-functional alignment. These skills and qualifications are crucial to ensure product safety, regulatory compliance, and the overall success of medical device manufacturing and delivery.

What are some common challenges quality managers face when ensuring compliance in the medical device industry?

Quality Managers in the medical device industry often encounter challenges such as keeping up with evolving regulatory requirements (like FDA, ISO 13485, and MDR), coordinating cross-functional teams to maintain strict quality standards, and managing documentation for audits. They must also address nonconformities quickly and implement corrective and preventive actions to avoid product recalls. Effective communication and strong attention to detail are essential for navigating these challenges while maintaining product safety and regulatory compliance.

What is the difference between Quality Manager Medical Device vs Quality Engineer Medical Device?

AspectQuality Manager Medical DeviceQuality Engineer Medical Device
Primary FocusOversees quality systems, compliance, and team managementDesigns, develops, and implements quality testing and inspection processes
CertificationsISO 13485, Six Sigma, Lead AuditorISO 13485, Six Sigma, Certified Quality Engineer (CQE)
Work EnvironmentManagement, regulatory compliance, cross-department collaborationProduct testing, process improvement, technical analysis
Industry UsageUsed across organizations to ensure overall quality managementUsed in product development and testing phases

The main difference is that the Quality Manager Medical Device focuses on managing quality systems and compliance at a strategic level, while the Quality Engineer Medical Device concentrates on technical testing and process improvements. Both roles require similar certifications and work within the same industry but serve different functions within quality assurance.

What are the most commonly searched types of Quality Medical Device jobs in Wisconsin?

The most popular types of Quality Medical Device jobs in Wisconsin are:

What are popular job titles related to Quality Manager Medical Device jobs in Wisconsin?

For Quality Manager Medical Device jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Quality Manager Medical Device jobs in Wisconsin look for?

The top searched job categories for Quality Manager Medical Device jobs in Wisconsin are:

What cities in Wisconsin are hiring for Quality Manager Medical Device jobs?

Cities in Wisconsin with the most Quality Manager Medical Device job openings:

Quality Manager Medical Device jobs near you
Infographic showing various Quality Manager Medical Device job openings in Wisconsin as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $86,965 per year, or $41.8 per hour.

Quality Manager - Medical Device/ ISO 13485

Vonco Products LLC

Trevor, WI • On-site

Full-time

Posted 7 days ago

Job description

Job Type
Full-time
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.

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