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Manager Medical Device Operations Jobs in Wisconsin

Equiliem

Medical Device Technician

Madison, WI · On-site

$32 - $38/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

This role supports production operations through diagnostic activities, process improvement ... Ability to manage multiple priorities and work effectively under deadlines. * Strong verbal and ...

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 Quality Engineer

Madison, WI · On-site

$40 - $45/hr

... Operations, Engineering, and Materials Management to strengthen quality culture. Principal ... medical device experience preferred) Skills & Competencies: * Strong communication, coaching ...

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Manager Medical Device Operations information

What is a manager medical device operations?

A Manager Medical Device Operations oversees the daily activities and processes involved in manufacturing, distributing, and maintaining medical devices. They ensure that operations comply with regulatory standards, manage teams, and work to optimize efficiency, quality, and safety. This role often involves coordinating with other departments, handling audits, and implementing process improvements to meet organizational goals. They play a critical role in ensuring that medical devices reach healthcare providers and patients safely and on time.

What are some common challenges faced by a manager medical device operations, and how can they be addressed?

Managers in Medical Device Operations often face challenges such as ensuring compliance with strict regulatory standards, coordinating cross-functional teams, and managing supply chain complexities. Staying proactive with regulatory updates, fostering open communication among departments, and implementing robust quality management systems can help address these issues. Additionally, investing in staff training and process improvement initiatives can streamline operations and minimize delays or compliance risks.

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

To excel as a Manager Medical Device Operations, you need expertise in supply chain management, regulatory compliance (such as FDA and ISO standards), and operational leadership, typically supported by a bachelor’s degree in engineering, life sciences, or business. Familiarity with ERP systems, quality management software, and relevant certifications like Six Sigma or PMP are commonly required. Strong communication, problem-solving, and team leadership skills help drive cross-functional collaboration and continuous improvement. These competencies are essential for ensuring product quality, regulatory adherence, and efficient operations in a highly regulated industry.

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

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

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

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

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

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

Manager Medical Device Operations jobs near you
Infographic showing various Manager Medical Device Operations job openings in Wisconsin as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 17% Part Time, and 5% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Quality Manager - Medical Device/ ISO 13485

Vonco Products LLC

Trevor, WI • On-site

Full-time

Posted 3 days ago

New

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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