Document Control Specialist - Hybrid Medical Device QC

Smith & Nephew; Maple Plain (MN); Hybrid; USD 62,000 - 93,000; Full time

Benefits offered by this job

401k Matching

Tuition Reimbursement

Medical, Dental, Vision

Hybrid Work Model

Job summary

Smith+ Nephew in Maple Plain, MN is seeking a Documentation Control Specialist to ensure quality, accuracy, and audit readiness of materials supporting Integrity Orthopaedics technology.

You will review inspection documentation, verify data before batch disposition, and maintain compliant records while supporting a broader commercial launch; knowledge of FDA/ISO requirements is preferred.

Qualifications

• High school diploma required; technical training preferred.
• At least 2 years in quality or receiving inspection in medical devices or regulated environments.
• Ability to read engineering drawings and interpret specifications.
• Familiarity with FDA 21 CFR Part 820 and ISO 13485 requirements.

Responsibilities

• Review inspection and production documentation to support timely release of materials.
• Verify that inspection data and results are complete before batch disposition.
• Identify and document nonconforming materials in accordance with procedures.
• Maintain complete, accurate, and audit-ready inspection documentation.
• Communicate atypical and out-of-spec results to management.
• Maintain a clean, organized, and compliant inspection area.
• Follow the Code of Conduct, Quality Policy, and all applicable policies, processes, and procedures.
• Support other areas of the organization as needed.

Skills

Attention to detail

Teamwork

Communication skills

Interpersonal skills

Education

High school diploma or equivalent

Technical or vocational training preferred

Tools

Measurement equipment (calipers, micrometers, vision systems)

Job description

Smith+ Nephew in Maple Plain, MN is seeking a Documentation Control Specialist to ensure quality, accuracy, and audit readiness of materials supporting Integrity Orthopaedics technology.

You will review inspection documentation, verify data before batch disposition, and maintain compliant records while supporting a broader commercial launch; knowledge of FDA/ISO requirements is preferred.