Logo
Actalent

Document Control Specialist

Actalent, Minneapolis, Minnesota, United States, 55400

Save Job

Document Control Specialist

As a Document Control Specialist, you will be responsible for reviewing documentation for new, revised, custom, and foreign products to ensure complete official documentation records required for manufacturing medical products. You will coordinate with the Engineering team to prepare new and revised product DMR and MM configurations and documentation using necessary systems like PLM, ERP, and UDI database systems. Your role will involve managing various types of engineering change orders and reviews, standardizing formats, proofreading for clarity, verifying configurations, and submitting documents for approval. You will update personnel on open projects and assist in formalizing documentation. Additionally, you will support regulatory inspections and audits while maintaining quality system controls to ensure compliance. Responsibilities

Review documentation for new, revised, custom, and foreign products to ensure complete official documentation records. Coordinate with the Engineering team to prepare new and revised product DMR and MM configurations using PLM, ERP, and UDI database systems. Manage ECOs, Production ECOs/ECRs, Sustaining Change ECOs/ECRs, DMR review, SAP/Pre-Checks, and SAP review. Standardize formats, proofread for errors or clarity, and verify configurations. Submit documents for approval, coordinate corrections and changes, and issue documentation packages. Update appropriate personnel on open projects. Assist and communicate with engineering, marketing, and regulatory bodies in preparing new or revised product documentation packages. Maintain quality system controls to ensure compliance. Support incoming inspection, regulatory inspections, and audits as needed. Essential Skills

Document control Quality control 2+ years experience with Grand Avenue Software Quality assurance Inventory control Data entry Microsoft Office proficiency Shipping and receiving Document management ISO standards Engineering change orders SAP ERP Quality control within medical devices Additional Skills & Qualifications

Self-starter with the ability to work independently or as part of a team. Ability to manage multiple projects simultaneously and meet deadlines. Excellent verbal and written communication skills. Basic knowledge of Microsoft programs, particularly Outlook, Word, and Excel. Strong organizational, troubleshooting, and problem-solving skills. Ability to perform structured decision-making on a daily basis. Strong interpersonal skills to interact with all levels of personnel professionally. Pay and Benefits

The pay range for this position is $25.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type

This is a fully onsite position in Brooklyn Park, MN. Application Deadline

This position is anticipated to close on Sep 8, 2025. About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actALENTaccommodation@actalentservices.com for other accommodation options.