Document Control Specialist

Actalent; Minneapolis (MN); On-site; USD 62,000 - 73,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k plan

Life Insurance

Disability insurance

HSA

Time Off

Job summary

Actalent is seeking a Document Control Specialist in Minneapolis, MN to manage engineering and product documentation within a regulated medical device environment. You will oversee GDP practices, maintain BOMs, and coordinate with cross-functional teams to support product releases.

This contract-to-hire role focuses on quality system compliance (ISO, FDA) and requires experience with PDM/ERP systems, QMS tools, and MS Office.

Qualifications

• 3+ years in a medical device environment focusing on documentation and quality system activities.
• Knowledge of ISO and FDA Quality System Regulation requirements including ISO 9001 and 21 CFR Part 820.
• Experience with Engineering/Product Data Management (PDM) systems and GDP practices.
• Proficiency with MS Office tools (Word, Excel, Visio, PowerPoint, Adobe Pro).
• Experience with QMS, GMP practices, and lifecycle data like BOMs in ERP/MRP systems.

Responsibilities

• Manage and maintain engineering/product documentation per ISO/FDA requirements.
• Administer and maintain Product Data Management (PDM) systems and ensure current product records.
• Implement and monitor GDP across documentation workflows and processes.
• Create/maintain lifecycle data including BOMs and master data in MRP/ERP systems.
• Ensure documentation changes are reviewed, approved, released, and archived per procedures.
• Collaborate with engineering, quality, manufacturing for timely document changes and releases.
• Support configuration management to maintain documentation consistency through the lifecycle.
• Track, retrieve, and report documentation status using databases and systems.
• Prepare and edit documents using MS Word, Excel, Visio, Acrobat Pro, PPT.
• Coordinate training documentation with LMS administrators.
• Support both paper-based and electronic QMS/e-QMS documentation.
• Assist audits/inspections with controlled documents and evidence of compliance.
• Prioritize multiple tasks and adapt to changing timelines.
• Contribute to continuous improvements in document control and quality processes.

Skills

GDP implementation

QMS experience

Documentation management

ISO/FDA knowledge

MS Office proficiency

Tools

AutoCAD

SolidWorks

Pro/ENGINEER

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.