Medical Device Quality Inspector

Stellar IT Solutions LLC; Madison (WI); On-site; USD 55,000 - 85,000; Full time

Job summary

Stellar IT Solutions LLC in Madison, WI seeks a Quality Assurance professional to ensure materials, processes and device manufacturing meet GMP and ISO13485 standards within the quality system.

You will inspect raw materials, perform in-process checks, review final documentation and packaging, support documentation control, and assist investigations of nonconformances to uphold regulatory compliance across manufacturing, engineering and quality teams.

Qualifications

• High School diploma or equivalent.
• Experience in a regulated work environment preferred.
• Knowledge of FDA QSR and ISO13485 pertaining to medical device manufacturing.

Responsibilities

• 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 Madison Manufacturing documentation control room.
• Completes documentation of activities performed, prepares and attaches material quality status labeling.
• Supports investigations of nonconformance and preventive actions within QA.

Skills

Attention to detail

Written communication

Team collaboration

Computer systems

Education

HS diploma

Tools

Electronic documentation systems

Job 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 preferred
  • Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device manufacturing

Competencies

• High Level of motivation; ability to work independently
• Detailed oriented
• Ability to work with computer-based systems daily
• Collaborator with strong levels of engagement with individuals and as a team member
• Good interpersonal skills; ability to communicate well, both verbally and written

Organizational Relationship/Scope

Reports to the Quality Control Manager. This position is accountable for delivery of prompt investigative work and detailed reporting. Working across multiple functions, this position collaborates primarily with manufacturing, engineering and quality to assess nonconforming product and support supplier quality issues.

Working Conditions

Manufacturing facility of medical devices and accessories. Controlled environmental working conditions.