Document Control Specialist

Talentify; Minneapolis (MN); On-site; USD 41,000 - 48,000; Full time

Benefits offered by this job

Medical/dental/vision

401(k) Retirement Plan

Life Insurance

Disability coverage

HSA

Job summary

Actalent is seeking a Document Control Specialist for a contract-to-hire role in Minneapolis, MN. The position focuses on managing engineering and product documentation in a regulated medical device environment, ensuring GDP and compliance with ISO, FDA 21 CFR 820, and EU MDR.

You will administer PDM/ERP data, maintain BOMs and lifecycle records, support audits, and collaborate with engineering, quality, and manufacturing to implement continuous improvements across documentation workflows.

Qualifications

• 3+ years in a medical device environment with documentation and quality system activities.
• Familiar with ISO 9001 and FDA 21 CFR Part 820 requirements.
• Experience with Engineering/Product Data Management (PDM) systems.
• GDP implementation and maintenance across documentation workflows.

Responsibilities

• Manage and maintain engineering and product documentation per ISO/FDA requirements.
• Administer PDM systems to keep records, drawings and specs current.
• Implement GDP across documentation workflows and processes.
• Maintain BOMs and master data in ERP/MRP systems.
• Review, approve, release, and archive changes per QMS procedures.
• Collaborate with engineering, quality, and manufacturing on document changes and releases.
• Support configuration management to ensure lifecycle documentation consistency.
• Track documentation status and metrics using databases and reporting tools.
• Prepare, format and edit documents using MS Word/Excel/Visio/PowerPoint.

Skills

Medical device experience

GDP knowledge

ISO 9001

FDA CFR 820

PDM/ERP systems

MS Office

Documentation control

Tools

AutoCAD

SolidWorks

Pro/ENGINEER (Pro E)

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.
• Background in product lifecycle management and medical device documentation processes.

Job Type & Location

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

Pay and Benefits

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)

Workplace Type

This is a fully onsite position in Minneapolis,MN.

Application Deadline

This position is anticipated to close on Oct 8, 2026.

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 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 process due to a disability, please email [e-mail] for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.