Document Control Specialist

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

Life. Unlimited. At Smith+ Nephew we design and manufacture technology that takes the limits off living.

Join our Operations team and help ensure the quality, accuracy, and compliance of materials supporting the manufacture of innovative medical technology. As a Documentation Control Specialist in Maple Plain, you will play an important role in protecting patient safety and product quality while supporting the broader commercial launch of Integrity Orthopaedics technology.

What will you be doing?

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

What will you need to be successful?

• A high school diploma or equivalent is required, with technical or vocational training in a related field preferred
• At least 2 years of quality or receiving inspection experience within the medical device industry or another regulated environment
• Understanding of FDA 21 CFR Part 820 and ISO 13485 requirements, along with experience using sampling plans and inspection methodologies
• Ability to read and interpret engineering drawings and specifications and use measurement equipment such as calipers, micrometers, and vision systems
• Strong attention to detail, organization, teamwork, communication, and interpersonal skills
• Ability to stand and perform inspection activities for extended periods, with a demonstrated commitment to patient safety, product quality, and company values

You. Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• **Inclusion and Belonging-** Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

The anticipated base compensation range for this position is $61,750.00 - 92,750.00 USD annually.

The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate.

In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings

Smith+Nebhew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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