Document Control Specialist

Smith & Nephew; Northern (KY); Hybrid; USD 62,000 - 93,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Discounted Stock Purchase Plan

Paid Holidays

Flexible Personal/Vacation Time Off

Health, Dental, Vision insurance

Job summary

Smith+ Nephew is seeking a Documentation Control Specialist in Maple Plain to ensure materials released for manufacture meet FDA and ISO requirements. You will review inspection records, manage nonconforming materials, and maintain audit-ready documentation while supporting a compliant work environment.

Ideal candidates have a high school diploma with related training plus 2+ years in medical device quality or regulated settings, and strong attention to detail.

Qualifications

• 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.

Responsibilities

• Review inspection and production documentation to support timely release of materials and ensure procedures are followed.
• Verify inspection data and results are complete and accurate before batch disposition.
• Identify and document nonconforming materials per company procedures.
• Maintain 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 applicable policies and procedures.
• Support other areas of the organization as needed.

Skills

FDA 21 CFR Part 820 knowledge

ISO 13485

Read engineering drawings

Inspection methodologies

Calipers

Micrometers

Vision systems

Attention to detail

Teamwork

Communication

Education

High school diploma or equivalent

Technical or vocational training in related field

Tools

Calipers

Micrometers

Vision systems

Job description

Life. Unlimited. At Smith+… 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+ Nephew 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.

Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You.

You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer.

Smith+ Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+ Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.