Quality Control Inspector I

Medline Industries, Inc.; Eagan (MN); Vor Ort; USD 26.000 - 37.000; Vollzeit

Benefits dieser Stelle

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Zusammenfassung

Medline Industries, LP is seeking a QC Inspector to support on the clean room production floor. You will inspect, review quality records, and assist with investigations to drive timely quality issue resolutions.

The role contributes to product quality, regulatory compliance, and continuous improvement initiatives, with a focus on risk reduction and CAPA effectiveness within GMP/ISO contexts.

Qualifikationen

• High school diploma or equivalent required.
• Ability to read, write, speak and understand English.
• Detail-oriented with basic math/measurement skills.
• Able to lift up to 50 lbs and work in PPE.

Aufgaben

• Perform incoming, in-process, and finished product inspections using approved sampling plans and methods.
• Review DHRs, batch records, sterilization docs, and manufacturing records for completeness and compliance.
• Support release activities for finished products and ensure 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/verification activities including process and test method validation.
• Support supplier quality activities including receiving inspections and issue tracking.
• Maintain quality metrics and prepare reports for management review.
• Assist during internal, customer, regulatory, and certification audits.
• Comply with SOPs, Quality Systems, OSHA guidelines, and Medline rules.

Kenntnisse

English proficiency

Attention to detail

Math skills

PPE safety

Lifting 50 lbs

Ausbildung

High School Diploma or equivalent

Jobbeschreibung

Job Summary

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. This position contributes directly to product quality, regulatory compliance, and continuous improvement initiatives.

Job Description

MAJOR 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 release activities for finished products 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 used 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.

MINIMUM JOB REQUIREMENTS:

Education:

• Typically requires High School Diploma or equivalent.

Certification / Licensure:

• No experience required.

Work Experience:

• None

Knowledge / Skills / Abilities:

• Ability to read, write, speak and understand English.


• Attention to details.


• 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.


• Position requires:


• Working in hot and cold environments.


• Sitting, walking or standing for prolonged periods, with frequent twisting and bending.


• Working 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 all relevant details, understanding and prioritizing their importance and drawing concise conclusions.


• Basic computer skills.


• Ability to apply basic knowledge of quality regulations such as GMP, GDP, ISO, or 21CFR 820, 210 - 211.

PREFERRED JOB REQUIREMENTS:

Education:

• None

Certification / Licensure:

• None

Work Experience:

• 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)

Knowledge / Skills / Abilities:

• None

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$18.50 - $26.75 Hourly

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.