Document Control Specialist
Job
Actalent
Eden Prairie, MN (In Person)
$71,372 Salary, Full-Time
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Job Description
Job Title:
Document Control Specialist Job Description 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 the manufacture of medical products. You will work in coordination with the Engineering team to prepare new and revised product DMR and MM configurations and documentation using required PLM, ERP, and UDI database systems. Responsibilities Manage ECOs, Production ECOs/ECRs, Sustaining Change ECOs/ECRs, DMR review, SAP/Pre-Checks, and SAP review. Review DMR-related documents and attachment files submitted for creation or changes. Standardize formats, proofread for errors or clarity, and verify configuration. Submit documents for approval signatures and coordinate corrections and changes by approvers. Issue documentation packages and update appropriate personnel on open projects as required. Assist and communicate with engineering, marketing, and regulatory bodies in preparing new or revised product documentation packages. Follow regulatory requirements, internal procedures, and most recent guidance available in Design Control, DMR, change management, and inspection. Maintain quality system controls to ensure compliance. Support incoming inspection (quality focused), regulatory inspections, and audits as needed. Essential Skills Proficiency in document control and quality control within medical devices. Experience with ERP systems, quality assurance, and inventory control. Proficient in Microsoft Suite including Outlook, Word, Excel, etc. Familiarity with ISO standards and engineering change orders. Experience with SAP and document management. Additional Skills & Qualifications Self-starter with good work ethic and ability to work independently with minimal supervision. Capability to manage multiple projects simultaneously and meet deadlines. Excellent verbal and written communication skills. Strong organizational, troubleshooting, and problem-solving skills. Ability to analyze details and perform structured decision-making daily. Strong interpersonal skills with the ability to interact with all levels of personnel professionally. Work Environment The work environment is very relaxed with a family-first mindset. The company fosters a collaborative culture where everyone feels part of the team. They do a great job at including the whole group in various activities such as team lunches, outings, happy hours, and events. Job Type & Location This is a Contract position based out of Eden Prairie, MN. Pay and Benefits The pay range for this position is $25.00 - $35.00/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 Eden Prairie,MN.
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