Medical Device Quality Inspector

Lenmar Consulting Inc; Madison (WI); On-site; USD 38,000 - 55,000; Full time

Job summary

Lenmar Consulting Inc seeks a Medical Device Quality Inspector to ensure quality integrity of medical devices. Responsibilities include inspecting materials, conducting in-process inspections, and supporting documentation controls. Ideal candidates have a strong attention to detail, effective communication skills, and familiarity with FDA regulations in a manufacturing environment.

Qualifications

• Education: High School diploma or equivalent.
• Experience: One year in a regulated work environment preferred.
• Knowledge: Familiarity with FDA regulations and ISO 13485.

Responsibilities

• Inspecting raw materials to meet production requirements.
• Conducting in-process inspection of manufacturing products.
• Reviewing final documentation for medical devices.

Skills

Attention to detail

Communication skills

Team collaboration

Computer proficiency

Motivation

Education

High School diploma or equivalent

Job description

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Position Summary

We're looking for a dedicated Medical Device Quality Inspector to join our team. In this role, you'll play a critical part in ensuring the quality integrity of our medical devices. You'll verify that materials, activities, processes, and conditions throughout manufacturing and packaging meet current Good Manufacturing Practice (GMP) standards and comply with our company's quality system and medical device regulations.

Key Responsibilities

You will perform one of three essential functions within our Quality department:

• Inspecting raw materials to meet production requirements.
• Conducting in-process inspection of manufacturing products and processes.
• Reviewing final documentation and shipment packaging for medical devices, subassemblies, and kits.
  
  

Additionally, You'll Be Responsible For

• Assisting in the documentation control room.
• Completing thorough documentation of all activities and applying material quality status labeling.
• Ensuring the controlled and secure storage and handling of products and labeling.
• Supporting Quality through occasional investigations of non-conformances and assisting with preventive actions.
• Performing quality reviews for quarantine releases.
  
  

Minimum Requirements

• Education: High School diploma or equivalent.
• Experience: One year of experience in a regulated work environment is preferred.
• Knowledge: Familiarity with FDA Quality System Regulations and ISO 13485 pertaining to medical device manufacturing.
• Skills & Competencies:
• Highly motivated and able to work independently.
• Strong attention to detail.
• Proficient with computer-based systems.
• Collaborative team player with strong engagement.
• Excellent interpersonal, verbal, and written communication skills.
  

Working Conditions

This position is based in a controlled environment within a medical device manufacturing facility.

If you're detail-oriented and committed to quality within a regulated environment, we encourage you to apply!

To be considered for other opportunities, you may send your updated resume to [e-mail]

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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