American Society for Quality (ASQ), Analysis Skills, Artificial Intelligence (AI), Biology, Biotech and Pharmaceutical, Business Administration, Candidate Screening, Change Control, Change Requests/Orders, Code of Federal Regulations, Communication Skills, Continuous Improvement, Control Systems, Corporate Policies, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Support/Service, Data Entry, Data Quality, Design Services, Detail Oriented, Document Archiving, Document Control, Document Management, Documentation, Documentation Standards, Engineering Change Management, Engineering Change Order, FDA (Food and Drug Administration), Genetics, Healthcare, Healthcare Quality, ISO (International Organization for Standardization), Industry Standards, Information/Data Security (InfoSec), Maintain Compliance, Manufacturing Operations, Medical Equipment, Metrics, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Multitasking, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Product Support, Productivity Management, Quality Control, Quality Management, Quality System Requirements (QSR), Record Keeping, Records Management, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Management, Standard Operating Procedures (SOP), Support Documentation, Technical/Engineering Design, Time Management, Work From Home, Writing Skills, eCos
Job Title: Document Control SpecialistJob Description
The Document Control Specialist administers and maintains the company's document control system to ensure full compliance with medical device regulations and quality management system requirements. This role manages controlled documents and quality records throughout their lifecycle so they are accurately reviewed, approved, distributed, revised, archived, and retained in line with company procedures and regulatory standards, including FDA 21 CFR Part 820, Good Documentation Practices, and other applicable global regulations. The position offers the opportunity to support a growing product line and gain valuable experience in the medical device industry.
Responsibilities
- Manage the complete document lifecycle, including creation, review, approval, distribution, revision, obsolescence, and archival of controlled documents.
- Maintain both electronic and paper-based document control systems, ensuring document accuracy, completeness, and easy accessibility.
- Process Engineering Change Orders (ECOs), Document Change Orders (DCOs), and related documentation updates in a timely and compliant manner.
- Ensure prompt routing and approval of Standard Operating Procedures (SOPs), Work Instructions, Forms, Specifications, Device Master Records (DMRs), and other quality records.
- Maintain detailed revision histories and document traceability in accordance with quality system requirements.
- Support compliance with FDA Quality System Regulations (QSR), Good Documentation Practices, MDSAP, and other applicable regulatory requirements.
- Perform periodic audits of controlled documentation to verify accuracy, completeness, and regulatory compliance.
- Coordinate document issuance and associated training assignments for new or revised procedures, ensuring relevant personnel are informed and trained.
- Maintain records retention and archival processes in line with company policies and regulatory requirements.
- Assist with internal, customer, and regulatory audits by locating, preparing, and providing requested documentation and records.
- Support quality system activities including Corrective and Preventive Actions (CAPA), Nonconformance Reports (NCR), Risk Management files, and other quality records.
- Track and report document control metrics such as approval cycle times, overdue reviews, and document status to support continuous improvement.
- Collaborate closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and Operations teams to ensure documentation accurately reflects current processes.
- Ensure document templates, numbering systems, and formatting standards are consistently applied across all controlled documents.
- Participate in continuous improvement initiatives related to quality system documentation and document management processes.
- Provide accurate data entry and quality control support to maintain high standards of documentation integrity.
Essential Skills
- Associate's degree in Business Administration, Life Sciences, Engineering, Quality, or a related field.
- Minimum 2 years of document control experience in a regulated industry.
- Experience in the medical device, pharmaceutical, biotechnology, or healthcare industry strongly preferred.
- Experience working in a medical device or other highly regulated industry.
- Knowledge of FDA 21 CFR Part 820 and Good Documentation Practices (GDP).
- Experience with Electronic Document Management Systems (eDMS) such as MasterControl, ETQ, Veeva, Arena, or similar platforms.
- Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
- Strong organizational skills with exceptional attention to detail.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Thorough understanding of document control principles and records management.
- Ability to maintain confidentiality and protect data integrity.
- High level of accuracy and a strong commitment to quality.
- Strong quality control and data entry skills.
Additional Skills & Qualifications
- Bachelor's degree in Business Administration, Life Sciences, Engineering, Quality, or a related field.
- Experience supporting FDA inspections, ISO audits, or MDSAP audits.
- Working knowledge of change control, CAPA, risk management, and quality system processes.
- ASQ or other quality-related certifications.
- Familiarity with medical device quality systems and regulatory expectations.
- Strong analytical and problem-solving skills.
- Customer service orientation and the ability to work effectively with cross-functional teams.
- Interest in contributing to a growing product line and expanding experience in the medical device industry.
Work Environment
This role operates in a remote work environment, providing flexibility while supporting a regulated, quality-focused organization. You will work extensively with electronic document management systems and standard office productivity tools to manage and maintain controlled documentation. Collaboration is primarily virtual, involving regular interaction with Quality, Regulatory Affairs, Engineering, Manufacturing, and Operations teams. The position emphasizes accuracy, compliance, and timely communication within a structured yet dynamic setting aligned with medical device industry standards.
Job Type & Location
This is a Contract position based out of Miami, FL.
Pay and Benefits
The pay range for this position is $28.00 - $34.00/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 remote position.
Application Deadline
This position is anticipated to close on Jul 31, 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 actalentaccommodation@actalentservices.com 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.