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Senior Validation Quality Engineer

Senior Validation Quality Engineer

JobilitySturtevant, WI, US
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Job Description

Job Title : Validation Quality Engineer (Senior / Intermediate)

Location : Sturtevant, WI

Duration : 6-Month Contract

Work Arrangement : 100% On-Site (No remote candidates)

Work Authorization : Lawful Permanent Residents only

A Brief Overview

This position provides validation, engineering, and technical support for facilities involved in manufacturing and distribution. The role coordinates and executes product and process validations within the Quality Department, ensuring compliance with applicable Quality Standards and Regulations. It also supports Quality Management and other departmental activities as needed.

Key Responsibilities

Validation & Process Support

  • Oversee the Quality System processes for product, process, and / or test method validation and re-validation.
  • Manage Installation, Operational, and Performance Qualification (IQ / OQ / PQ) activities for equipment and computerized systems.
  • Support installation and configuration of new equipment.
  • Assist R&D and Manufacturing with new product and process development and validation.
  • Review and approve internal procedures and specifications.

Compliance & Quality Support

  • Capture and analyze data on deviations, non-conformances, CAPAs, scrap, and rework for Quality Improvement.
  • Lead and promote quality improvement processes and reporting systems.
  • Provide engineering support for supplier changes and issue resolution.
  • Ensure compliance with federal, state, and local regulations for medical device manufacturing.

    • Inspections & Audits

  • Support federal, state, and local inspections.
  • Participate in internal and vendor quality audits.

    • Training & Other Duties

  • Deliver assigned training tasks within the quality training program.
  • Perform other duties as assigned by Quality Management.

    • Minimum Requirements

    For Intermediate Validation Quality Engineer

  • Bachelor’s Degree in Physical Science, Engineering, or equivalent experience.
  • Minimum 2 years in Medical Device, Pharmaceutical, or similar regulated industry.
  • Minimum 2 years in a Quality role.
  • Minimum 2 years in a Validation Engineering role.

    • For Senior Validation Quality Engineer

  • Bachelor’s Degree in Physical Science, Engineering, or equivalent experience.
  • 3–5 years in Medical Device, Pharmaceutical, or similar regulated industry.
  • 3–5 years in a Quality role.
  • 3–5 years in a Validation Engineering role.

    • Preferred Qualifications

    Intermediate Level

  • Minimum 2 years working with electromechanical devices.
  • ASQ Certification (CQE or equivalent).

    • Senior Level

  • Minimum 3 years working with electromechanical devices.
  • ASQ Certification (CQE preferred).

    • Technical & Functional Skills

  • In-depth knowledge of quality requirements in medical device / pharma environments.
  • Strong technical writing and general problem-solving skills.
  • Experience with Client / CAPA processes.
  • Proficient in Microsoft Word, Excel, PowerPoint, Visio, Adobe, and Quality System Management Software.
  • Skilled in statistical data analysis and process validation sampling requirements.
  • Familiarity with ISO 13485, FDA QSRs, GMPs, and / or international medical device regulations.
  • Strong communication skills and ability to work cross-functionally.
  • Capable of managing multiple priorities and working independently with minimal supervision.
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