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Temporary Manager Medical Device Jobs in Wisconsin

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Production Operator

Baldwin, WI · On-site

$19 - $21/hr

... Full Time (Temp-to-Hire) Experience: Entry Level Join a Growing Leader in Medical Plastics ... Previous experience in plastics or medical device manufacturing is a plus, but not required -- we ...

Design Hire LLC

Quality Manager

Racine, WI

$85K - $100K/yr

Medical device manufacturing experience strongly preferred. * Working knowledge of FDA audit ... Temporary work authorization or the need for sponsorship may disqualify you from employment.

Design Hire LLC

Quality Manager

Racine, WI · On-site

$100 - $125/hr

Medical device manufacturing experience strongly preferred. * Working knowledge of FDA audit ... Temporary work authorization or the need for sponsorship may disqualify you from employment. #J ...

Hologic, Inc.

WI · On-site

$125 - $150/hr

Experienced with FDA-Medical Devices-820 Quality System Regulation, especially Design Control requirements, ISO 13485 Medical Device Quality management System,ISO 14971:2019, Risk Management ...

Verily Life Sciences LLC

WI · On-site

$125 - $150/hr

Demonstrated experience applying IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), IEC 62366 (Usability Engineering), and AAMI TIR57 within a regulated software ...

Exalta Group

Quality Assurance Specialist

Kenosha, WI · On-site

$65K - $75K/yr

Knowledge of Medical Device Risk Management Regulation ISO 14971. * Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization. * Advanced knowledge ...

Valid8 Financial, Inc.

Quality Manager

Oak Creek, WI · On-site

$100 - $125/hr

The Quality Manager leads daily quality operations within a medical device manufacturing environment, ensuring products, processes, and documentation meet FDA, ISO 13485, and internal quality system ...

Hologic, Inc.

WI · On-site

$100 - $125/hr

Experienced with FDA-Medical Devices-820 Quality System Regulation, especially Design Control requirements, ISO 13485 Medical Device Quality management System,ISO 14971:2019, Risk Management ...

Leo Cancer Care Ltd

WI · On-site

$125 - $150/hr

Mentor less experienced engineers in interoperability standards and medical device software practices. * Manage contractors relating to softwarecomponentdevelopment where applicable. Relevant ...

Collabera

Engineering project manager

Madison, WI · On-site

Industry: Healthcare/Medical device Title: Engineering project manager Location: Madison, WI 53718 Qualifications Critical Needs: BS Mechanical Engineer is preferred, or any other engineering degree ...

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Temporary Manager Medical Device jobs near you
Infographic showing various Temporary Manager Medical Device job openings in Wisconsin as of June 2026, with employment types broken down into 1% As Needed, 35% Full Time, 54% Part Time, 2% Temporary, 6% Contract, and 2% Nights. Highlights an 98% Physical, 1% Hybrid, and 1% Remote job distribution.

Regulatory Quality Engineer

Arch-Medical-Solutions

Kenosha, WI • On-site

$100 - $125/hr

Other

Posted 19 days ago

Job description

  • Acts as a Quality System Management Representative for the Elmhurst (IL) and Kenosha (WI) facilities.
  • Ensures the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization. Assists in training personnel on all aspects of the Quality System and regulatory standards.
  • Ensures that processes needed for the quality management system are established, implemented, and maintained.
  • Complies with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation - 21 CFR 820, GMP guidelines, GDP, ISO 13485, ISO and other applicable regulatory requirements.
  • Leads and/or participates in the development, implementation, compliance, and maintenance of standards (FDA, ISO 13485:2016, etc.) and procedures.
  • Acts as a direct contact for FDA. Ensures FDA registrations and device listings are current.
  • Participates and supports the ECO, CAPA, MRB and other Quality System processes.
  • Creates metrics that drive effective monitoring of processes, value-add improvements and communication at all levels of the organization.
  • Develops and implements process flows in cooperation with functional groups.
  • Ensures risk assessment activities are executed and maintained according to regulatory standards.
  • Organizes investigation activities and coordinates appropriate resources to drive for root cause determinations, correction action implementation and effectiveness verification.
  • Leads vendor, internal/external, and process audits at both facilities and provides necessary documentation.
  • Performs validation training. Establishes and maintains master validation program, including site and individual products and process master validations.
  • Designs and oversees training program(s), including ISO internal training.
  • Responsible for internal and external audits.
  • Interferes with suppliers to resolve quality issues.
  • Coordinates manufacturing process validation requirements, documentation and maintenance of validated processes with internal and external stakeholders.
  • Other duties as assigned.

Qualifications

  • Bachelor's degree in applicable technical discipline such as mechanical or bio-medical engineering is strongly preferred or equivalent,
  • or five to ten years of experience in medical device manufacturing industry and in the quality engineering role, and/or training,
  • or equivalent combination of education and experience.
  • Knowledge of the medical device manufacturing industry.
  • Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.
  • Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M.
  • Familiarity with test methods and standards for the design, verification, and validation of medical device products is required.
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Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.

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