Quality Inspector in Madison

Energy Jobline ZR

Madison (WI)

On-site

USD 50,000 - 70,000

Full time

11 days ago

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Job summary

Select Source International (SSI) in Madison, WI is seeking a Quality Inspector to ensure materials, processes and finished devices meet GMP and ISO13485 standards.

The role conducts material and in-process inspections, maintains documentation, and supports investigations of nonconformances to uphold product quality and regulatory compliance. The position emphasizes accurate labeling, controlled storage, and collaboration with QA in a regulated medical device environment.

Qualifications

  • High School diploma or equivalent.
  • One year’s experience in a regulated work environment.
  • Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device manufacturing.

Responsibilities

  • Inspections of raw materials to meet production requirements.
  • In-process inspection of manufacturing product and processes.
  • Reviews final documentation and shipment packaging for medical devices, subassemblies, and kits.
  • Assists in the Madison Manufacturing documentation control room.
  • Completes documentation of activities performed, prepares and attaches material quality status labeling.
  • Ensures storage and handling of product and labeling in a controlled and secure manner.
  • Supports Quality through occasional investigations of nonconformance, assists with preventive actions.
  • Performs quality reviews for quarantine releases on nonreportable, non-complaint, RMF-3 internal to an RSC.

Skills

Quality inspection
GMP
Regulatory compliance
Documentation

Education

High School diploma
1 year regulated work experience

Job description

Job DescriptionJob Description

Responsible for assuring that materials, activities, processes, and specified conditions related to the daily device manufacturing, processing and packaging meet current GMP standards and comply with applicable procedures and standards such as ensuring the quality integrity of the product. Ensure work is completed in compliance with the company quality system and medical device regulations. Ensure work is completed in compliance with the company quality system and medical device regulations.

Essential Functions
  • Performs one of three functions in the Quality department:
  • Inspecting raw materials to meet production requirements
  • Conducts in-process inspection of manufacturing product and processes
  • Reviews final documentation and shipment packaging for medical devices, subassemblies, and kits
  • Assists in the Madison Manufacturing documentation control room.
  • Completes documentation of activities performed, prepares and attaches material quality status labeling. Ensures storage and handling of product and labeling in a controlled and secure manner.
  • Supports Quality through occasional conduct of investigations of nonconformance, assists with preventive actions associated with the QA unit.
  • Performs quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC.
Minimum Requirements
Education / Experience / Skills:
  • High School diploma or equivalent
  • One year’s experience in a regulated work environment
  • Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device manufacturing

Company Description

Select Source International (SSI) is a distinguished workforce solutions provider with nearly 25 years of experience delivering top-tier staffing, recruiting, and managed services. Based in Minneapolis, Minnesota, SSI has established itself as a global leader, serving a broad, diverse clientele across industries with unwavering dedication and excellence.

As a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier .

Company DescriptionSelect Source International (SSI) is a distinguished workforce solutions provider with nearly 25 years of experience delivering top-tier staffing, recruiting, and managed services. Based in Minneapolis, Minnesota, SSI has established itself as a global leader, serving a broad, diverse clientele across industries with unwavering dedication and excellence.

As a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier .

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