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Medical Device Operations Jobs in Wisconsin (NOW HIRING)

Therakos

Medical Device Service Engineer

Madison, WI

Job Title Medical Device Service Engineer Requisition JR000015824 Medical Device Service Engineer ... operational capabilities. Responsible for training and support of other Service personnel that ...

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 ...

Natus Medical Incorporated

QA Technician

Middleton, WI · On-site

$22 - $25/hr

The Quality Technician you will ensure compliance with medical device quality and regulatory ... Responsible for ensuring all operations conducted meet the requirements for quality, products ...

Exalta Group

Quality Assurance Specialist

Kenosha, WI · On-site

$65K - $75K/yr

Supports the management of the day to day operation and responsibilities of document control to ... Knowledge of Medical Device Risk Management Regulation ISO 14971. * Ability to communicate ...

New

Resonetics

Senior Manufacturing Engineer

Hudson, WI

$78K - $124K/yr

Management of new and existing medical device programs. Responsibilities include maintaining ... Strong analytical skills with the ability to process operational or technical data and translate ...

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Medical Device Operations information

What is the difference between Medical Device Operations vs Medical Device Quality Assurance?

AspectMedical Device OperationsMedical Device Quality Assurance
Primary FocusManaging manufacturing, supply chain, and product deploymentEnsuring product quality, compliance, and safety standards
Required CertificationsRegulatory knowledge, manufacturing certificationsQuality management certifications, ISO standards
Work EnvironmentManufacturing plants, supply chain settingsQuality labs, compliance departments
Industry UsageUsed across production and logistics teamsUsed within quality control and regulatory teams

Medical Device Operations and Medical Device Quality Assurance roles often overlap but focus on different aspects of the product lifecycle. Operations centers on manufacturing and logistics, while Quality Assurance emphasizes compliance and safety. Both roles require regulatory knowledge and are essential in the medical device industry.

What are some common challenges faced by professionals in Medical Device Operations, and how can they be addressed?

Professionals in Medical Device Operations often face challenges related to maintaining strict regulatory compliance, ensuring product quality, and managing cross-functional communication between manufacturing, quality assurance, and regulatory teams. Staying up to date with changing FDA or international regulations is essential, and frequent documentation or process audits can be demanding. Building strong organizational habits, leveraging digital tracking tools, and fostering open communication channels with other departments can help address these challenges and ensure smooth operations.

What are medical device operations?

Medical device operations refer to the processes and activities involved in the manufacturing, assembly, quality control, supply chain management, and distribution of medical devices. This field ensures that devices are produced efficiently, meet regulatory standards, and are delivered safely to healthcare providers and patients. Operations teams collaborate with engineering, quality assurance, and regulatory departments to maintain compliance and optimize production workflows. Their work is crucial for ensuring that medical devices are safe, effective, and readily available for patient care.

What are the key skills and qualifications needed to thrive in Medical Device Operations, and why are they important?

To thrive in Medical Device Operations, you need a solid understanding of regulatory compliance, quality assurance, and supply chain management, often supported by a degree in engineering, life sciences, or business. Familiarity with quality management systems (QMS), FDA regulations, and software like ERP systems is typically required. Strong organizational skills, attention to detail, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring compliance. These competencies are vital for delivering safe, high-quality medical devices efficiently and in accordance with rigorous industry standards.
What are the most commonly searched types of Medical Device Operations jobs in Wisconsin? The most popular types of Medical Device Operations jobs in Wisconsin are:
What are popular job titles related to Medical Device Operations jobs in Wisconsin? For Medical Device Operations jobs in Wisconsin, the most frequently searched job titles are:
What job categories do people searching Medical Device Operations jobs in Wisconsin look for? The top searched job categories for Medical Device Operations jobs in Wisconsin are:
What cities in Wisconsin are hiring for Medical Device Operations jobs? Cities in Wisconsin with the most Medical Device Operations job openings:
Medical Device Operations jobs near you
Infographic showing various Medical Device Operations job openings in Wisconsin as of July 2026, with employment types broken down into 77% Full Time, 15% Part Time, and 8% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Medical Device Quality Inspector

Kellton Tech

Madison, WI • On-site

$30/hr

Contractor

Posted 2 days ago

Job description

Job Title: Medical Device Quality Inspector
Location: Madison, WI (Onsite)
Pay Rate: $30/hr. on W2

Job Summary

The Medical Device Quality Inspector is responsible for ensuring that materials, processes, and activities involved in daily device manufacturing, processing, and packaging meet current Good Manufacturing Practices (GMP) and comply with ISO 13485 and applicable quality standards. This position plays a key role in maintaining the quality integrity of medical device products through precise inspection and documentation.

Key Responsibilities

  • Inspect parts according to engineering drawings and specifications.
  • Perform dimensional inspections using precision tools such as calipers, micrometers, gage pins, plug gages, and thread gages.
  • Record acceptance data in the SAP ERP system after inspection.
  • Enter failure data into nonconforming material reports (NCMRs) when applicable.
  • Support daily production activities and collaborate with the team to meet quality and output goals.
  • Follow all established procedures in compliance with FDA and ISO 13485:2008 standards.
  • Maintain documentation in accordance with GMP and company policies.
  • Adapt to various inspection assignments and assist team members as needed.
  • Work overtime when required based on production schedules and incoming part volumes.

Desired Experience

  • Experience with optical measurement machines or a Coordinate Measuring Machine (CMM).
  • Familiarity with ISO 13485 or ISO 9001 quality management systems.
  • Prior experience with material or component inspection in a regulated environment preferred.
  • Exposure to computer-based quality systems; SAP experience is a plus (training provided).

Qualifications

  • Education: High School Diploma or equivalent.
  • Language: Ability to read and write in English.
  • Mathematical Skills: Basic math proficiency required.
  • Technical Skills:
  • Ability to use precision measurement tools such as calipers, micrometers, and thread gages.
  • Proficiency with Microsoft Word and Excel.
  • Soft Skills:
  • Strong attention to detail and defect identification.
  • Ability to work efficiently in a fast-paced team environment with minimal supervision.
  • Flexibility to work overtime as required.

About the Role

This is a hands-on quality inspection position within a team-oriented environment that supports manufacturing operations. The ideal candidate is detail-oriented, computer-proficient, and eager to learn inspection procedures under regulated (FDA and ISO 13485) conditions.