Cleanroom QC Inspector I - Medical Devices (2nd Shift)

TransMedics, Inc.; Andover (MN); On-site; USD 34,000 - 44,000; Full time

Benefits offered by this job

Medical with HRA

Dental

Vision

FSA

Dependent Care FSA

Short Term Disability

Long Term Disability

401K Plan

Employee Stock Purchase Plan

Job summary

TransMedics, Inc. is seeking a Quality Inspector for second shift (2:30 PM–11:00 PM) to inspect critical components and assemblies for Class III medical devices.

The role involves visual and dimensional inspection, interpreting drawings, and approving or returning products for re-work to ensure quality. Responsibilities include batch record review, documenting non-conformances, and ensuring compliance with CGMP/GDP and safety policies.

Qualifications

• 1–3 years of Quality Control experience in medical device manufacturing.
• High School Diploma or equivalent with relevant training or experience.
• Understanding of CGMP and GDP.
• Intermediate computer skills; MS Word/Outlook experience.
• Proficient in English; able to read and interpret drawings and specs.
• Comfort with reading calipers and measurement tools.
• Familiarity with inspection tools and quality documentation.

Responsibilities

• Perform intermediate visual and dimensional inspection during in-process or final assembly.
• Approve finished products by confirming specs and conducting tests.
• Review products for re-work and ensure conformity to specs.
• Ensure compliance with company policies, lot control, and safety.
• Identify non-conformances and document deviations.
• Conduct batch record reviews and release processes.
• Perform other tasks as assigned.

Skills

Quality systems (CGMP & GDP)

Intermediate computer skills

Read drawings/blueprints

Math skills

Inspection tools (ruler, calipers)

Education

High School Diploma or equivalent

Tools

Vernier calipers

Rulers

Tappi Charts (a plus)

Job description

TransMedics, Inc. is seeking a Quality Inspector for second shift (2:30 PM–11:00 PM) to inspect critical components and assemblies for Class III medical devices.

The role involves visual and dimensional inspection, interpreting drawings, and approving or returning products for re-work to ensure quality. Responsibilities include batch record review, documenting non-conformances, and ensuring compliance with CGMP/GDP and safety policies.