Document Control Specialist

Job Description

Job Description

Document Control Specialist

Job Description

The Document Control Specialist supports robust quality and regulatory compliance by managing engineering and product documentation within a highly regulated medical device environment. This role maintains accurate product data, bills of materials, and lifecycle records in PDM and MRP/ERP systems while ensuring adherence to ISO, FDA, and European medical device regulations. The specialist implements and upholds good documentation practices, partners closely with cross-functional teams, and helps streamline processes to support timely product development and release.

Responsibilities

• Manage, control, and maintain engineering and product documentation in alignment with ISO and FDA Quality System Regulation requirements, including ISO 9001, FDA 21 CFR Part 820, and European Medical Device Regulations.
• Administer and maintain Product Data Management (PDM) systems to ensure accurate and current product records, drawings, and specifications.
• Implement, monitor, and continuously improve good documentation practices (GDP) across documentation workflows and processes.
• Create, update, and maintain product lifecycle data, including bills of materials (BOMs) and master data, within MRP/ERP systems.
• Ensure that all documentation changes are properly reviewed, approved, released, and archived in accordance with quality system procedures.
• Collaborate with engineering, quality, manufacturing, and other stakeholders to support timely document changes and product releases.
• Support configuration management activities to maintain consistency of product documentation throughout the product lifecycle.
• Use computer databases and documentation systems to track, retrieve, and report on documentation status and metrics.
• Prepare, format, and edit documents, forms, and templates using MS Word, Excel, Visio, Adobe Pro, and PowerPoint.
• Coordinate training documentation and records in collaboration with Training and/or Learning Management Systems (LMS) administrators.
• Support both paper-based and electronic quality management systems (QMS/e-QMS) by ensuring documentation is complete, accurate, and compliant.
• Assist with audits and inspections by providing controlled documents, records, and evidence of compliance with applicable regulations and standards.
• Prioritize and manage multiple tasks and projects concurrently while adapting to changing priorities and timelines.
• Contribute to continuous improvement initiatives related to document control, product data management, and quality system processes.

Essential Skills

• 3+ years of experience in a medical device environment, with direct involvement in documentation and quality system activities.
• Knowledge of ISO and FDA Quality System Regulation requirements, including ISO 9001, FDA 21 CFR Part 820, and European Medical Device Regulations.
• Experience working with Engineering and/or Product Data Management (PDM) systems.
• Hands-on experience implementing and maintaining good documentation practices (GDP).
• Proficiency in managing product lifecycle data, including bills of materials (BOMs) and master data, in MRP/ERP systems.
• Strong understanding and working knowledge of computer databases and documentation systems.
• Proficiency with MS Office tools, including Word, Excel, PowerPoint, and Visio, as well as Adobe Pro.
• Experience with medical device product lifecycle management, quality control, quality assurance, and GMP practices.
• Experience using configuration management software and quality management system (QMS) tools.

Additional Skills & Qualifications

• Experience with Training and/or Learning Management Systems (LMS).
• Proficiency with AutoCAD, SolidWorks, Pro/ENGINEER (Pro E), or similar CAD software packages.
• Proficiency in both paper-based quality management systems (QMS) and electronic QMS (e-QMS) platforms.
• Familiarity with ERP/MRP bolt-on software used to control product BOMs and product geography releases.
• Work history in product lifecycle management and medical device documentation processes.

This is a Contract to Hire position based out of Minneapolis, MN.

The pay range for this position is $30.00 - $35.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

This is a Contract to Hire position based out of Minneapolis, MN.

This position is anticipated to close on Oct 21, 2026.

This is a fully onsite position in Minneapolis,MN.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.