Document Control Specialist

Title: Document Control Specialist

Location:

 Eden Prairie, Minnesota, USA

category Manufacturing, Mechanical, & Electrical

25 USD - 30 USD/hour

Job Description:

Part-Time: 20-30 Hours/Week

Job Description

The Document Control Specialist is responsible for reviewing and preparing documentation for new, revised, custom, and foreign medical products. This role involves coordinating with the Engineering team to manage product DMR and MM configurations and documentation using various database systems. The specialist will manage and oversee ECOs, ECRs, and other related documentation tasks to ensure compliance with regulatory requirements.

Responsibilities

• Review documentation for complete official records required to manufacture medical products.
• Prepare new and revised product DMR and MM configurations in coordination with the Engineering team.
• Manage ECOs, Production ECOs/ECRs, Sustaining Change ECOs/ECRs, and DMR reviews.
• Standardize formats, proofread for errors or clarity, and verify configurations.
• Submit documents for approval, coordinate corrections, and issue documentation packages.
• Update appropriate personnel on open projects as required.
• Assist and communicate with engineering, marketing, and regulatory bodies in documentation preparation.
• Support quality system controls and regulatory compliance.
• Participate in incoming inspections, regulatory inspections, and audits as needed.

Essential Skills

• Experience in document control and quality control within the medical device industry.
• Proficiency in Microsoft Suite, ERP systems, SAP, and document management.
• Strong organizational and problem-solving skills.
• Excellent verbal and written communication skills.
• Ability to manage multiple projects simultaneously and meet deadlines.

Additional Skills & Qualifications

• Self-starter with the ability to work independently and as part of a team.
• Strong interpersonal skills for interacting with personnel at all levels.
• Ability to analyze details and perform structured decision-making.
• Familiarity with ISO standards and engineering change orders.

Work Environment

The work environment is very relaxed with a family-first mindset. There is a strong sense of team inclusion with structured activities such as team lunches, outings, and events. The company offers a collaborative culture focused on career development in the innovative field of non-invasive tissue regeneration technology.

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 - $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 Eden Prairie,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 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  for other accommodation options.