Medical Device Quality Inspector

Medical Device Quality Inspector

Pay: $22$25/hrr, paid weekly Schedule: MondayThursday | 7:00 AM4:00 PM; Friday | 7:00 AM11:00 AM Location: Madison, WI 53718 Duration: 6-Month Contract

Summary

Support the quality assurance process for medical device manufacturing by inspecting materials, monitoring production, and verifying finished products meet FDA, GMP, and ISO quality standards. This role is ideal for someone with strong attention to detail who thrives in a regulated manufacturing environment.

Responsibilities

• Inspect incoming raw materials to ensure they meet quality and production requirements.
• Perform in-process inspections of manufacturing operations and products.
• Review final documentation, labeling, packaging, and shipments of medical devices, subassemblies, and kits.
• Maintain accurate quality documentation and apply material status labels.
• Ensure proper storage, handling, and control of products and quality records.
• Assist with documentation control activities within the manufacturing facility.
• Support investigations into nonconforming materials and products.
• Assist with quarantine releases and other Quality Assurance activities.
• Follow all GMP, FDA Quality System Regulations, ISO 13485, and company quality procedures.
• Maintain a clean, organized, and compliant work environment.

Qualifications

• High school diploma or GED required.
• At least 1 year of experience in a regulated manufacturing environment preferred.
• Knowledge of FDA Quality System Regulations (QSR), GMP, and ISO 13485 preferred.
• Strong attention to detail and commitment to quality.
• Comfortable using computer-based systems for documentation and recordkeeping.
• Ability to work independently and as part of a collaborative team.
• Strong verbal and written communication skills.

Work Environment

• Medical device manufacturing facility.
• Controlled manufacturing environment with established quality and safety procedures.

Benefits (Employee Contribution)

• Health insurance
• Health savings account (HSA)
• Dental insurance
• Vision insurance
• Flexible spending account (FSA)
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Pay within the stated range will be based on experience, skills, and qualifications.