Quality Control Inspector I

Medline • Eagan, MN

8d • Onsite

About The Position

The QC Inspector serves as a key quality presence on the clean room production floor, providing inspection support, reviewing quality records, assisting with investigations, and driving timely resolution of quality issues. The position contributes to product quality, regulatory compliance, and continuous improvement initiatives.

Requirements

• High school diploma or equivalent.
• No prior work experience required.
• Ability to read, write, speak, and understand English.
• Attention to detail.
• Vision abilities including close vision, distance vision, depth perception, and ability to adjust focus.
• Basic math skills, including addition, subtraction, and fractional-to-decimal conversions.
• Ability to work in hot and cold environments.
• Ability to sit, walk, or stand for prolonged periods, with frequent twisting and bending.
• Ability to work in PPE or company-issued gowns for prolonged periods.
• Ability to lift up to 50 lbs.
• Ability to prioritize quickly in a fast-paced manufacturing environment.
• Ability to process relevant details, understand and prioritize their importance, and draw concise conclusions.
• Basic computer skills.
• Ability to apply basic knowledge of quality regulations such as GMP, GDP, ISO, or 21 CFR 820 and 210–211.

Nice To Haves

• Experience in a medical device or other FDA-regulated manufacturing environment.
• Experience working in a cleanroom (ISO Class 7/8 or similar).
• Experience inspecting medical devices or components, incoming, in-process, or final.

Responsibilities

• Perform incoming, in-process, and finished product inspections using approved sampling plans and inspection methods.
• Review Device History Records (DHRs), batch records, sterilization documentation, and manufacturing records for completeness and compliance.
• Support finished-product release activities and ensure required quality documentation is complete and accurate.
• Assist with investigations related to nonconformances, deviations, complaints, supplier issues, and corrective actions.
• Support CAPA implementation, effectiveness verification, and follow-up activities.
• Assist with validation and verification activities, including process validation, test method validation, and sterilization-related studies.
• Support supplier quality activities, including receiving inspections, supplier issue tracking, and follow-up actions.
• Maintain quality metrics and prepare reports for management review and quality performance monitoring.
• Assist during internal, customer, regulatory, and certification audits.
• Comply with Standard Operating Procedures (SOPs), Quality Systems, OSHA guidelines, and Medline’s rules and regulations.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance for employees working 30 or more hours per week on average.
• Life and disability benefits for employees working 30 or more hours per week on average.
• 401(k) contributions.
• Paid time off.
• For employees working less than 30 hours per week, access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED