Medical Device Documentation Lead — Quality & Compliance

smithnephew; Town of Maple Plain (WI); Hybrid; USD 62,000 - 93,000; Full time

Benefits offered by this job

401k Matching Program

Discounted Stock Purchase Plan

Tuition Reimbursement

Paid Holidays

Flex Holidays

Medical, Dental, Vision coverage

Health Savings Account

Parental Leave

Hybrid Work Model

Mentorship

Job summary

Smith+Nephew is seeking a Documentation Control Specialist in Maple Plain to ensure the quality, accuracy, and compliance of materials supporting medical technology manufacturing. The role focuses on reviewing documentation, verifying inspection results, and maintaining audit-ready records to protect patient safety.

You will work within an Operations team with a hybrid work model, contributing to broader product launches while adhering to FDA and ISO quality systems and company policies.

Qualifications

• High school diploma or equivalent required; technical or vocational training preferred.
• At least 2 years of quality or receiving inspection experience in medical devices or regulated environments.
• Understanding of FDA 21 CFR Part 820 and ISO 13485 requirements and sampling plans.

Responsibilities

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

Skills

Quality inspection

Documentation control

Attention to detail

Reading drawings

Teamwork & communication

Education

High school diploma or equivalent

Technical or vocational training in related field preferred

Tools

Calipers

Micrometers

Vision systems

Job description

Smith+Nephew is seeking a Documentation Control Specialist in Maple Plain to ensure the quality, accuracy, and compliance of materials supporting medical technology manufacturing. The role focuses on reviewing documentation, verifying inspection results, and maintaining audit-ready records to protect patient safety.

You will work within an Operations team with a hybrid work model, contributing to broader product launches while adhering to FDA and ISO quality systems and company policies.