Doc Control Specialist

Document Control Specialist - Medical Device (Onsite, Irvine, CA) Be the quality gatekeeper during a pivotal transformation. We're partnering with a leading medical device organization undergoing a major post‑merger integration and quality system remediation effort. This is a rare opportunity for a Document Control Specialist to step into a highly visible, hands‑on role where your expertise directly strengthens compliance, accelerates integration, and shapes the future of a unified quality system. If you thrive in fast‑paced environments, enjoy working shoulder‑to‑shoulder with Engineering and Quality teams, and aren't afraid to hold the line on documentation standards, this role puts you at the center of the action. What You'll Own Drive the processing of Engineering Change Orders (ECOs) , document change requests, and quality records in alignment with FDA and ISO requirements. Review change packages with a sharp eye for completeness, accuracy, and proper change classification . Ensure every document meets quality expectations — formatting, pagination, signatures, approvals, impacted documents, and alignment between justification and scope. Confidently push back on incomplete or non‑compliant submissions , guiding engineers and stakeholders toward compliant, audit‑ready documentation. Support post‑merger remediation , including harmonizing document formats, numbering systems, and procedures across legacy and newly integrated systems. Assist with document migration and integration activities while maintaining traceability and regulatory compliance. Identify documentation gaps and inconsistencies, partnering with cross‑functional teams to drive corrective actions. Update CAD‑controlled documentation, including title blocks, revision histories, and metadata. Support Bill of Materials (BOM) updates and ensure alignment between drawings, specifications, and released documentation. Work directly with Engineering to ensure design outputs are properly controlled and released. Prepare, format, and update controlled documents using Microsoft Word and PowerPoint. Maintain document control logs and trackers, and support audits by retrieving documentation and explaining document control processes. What You Bring 3-5 years of document control experience within the medical device industry. Strong working knowledge of 21 CFR 820 , ISO standards, and document/change control best practices. Hands‑on experience processing ECOs and document change orders. A confident, professional approach to enforcing quality standards and challenging non‑compliant documentation. Proficiency in Microsoft Word and PowerPoint, including controlled document formatting. Experience with engineering drawings, CAD documentation, and BOM structures. Exceptional attention to detail, organization, and the ability to juggle multiple priorities in a dynamic onsite environment. Bonus Skills Experience supporting M&A integration or remediation initiatives. Familiarity with eQMS/PLM systems such as Agile, Windchill, Arena, or MasterControl. Strong interpersonal skills and the ability to collaborate closely with Engineering, Quality, and Regulatory teams. Work Environment & Perks This role is 100% onsite in Irvine, CA , working closely with Engineering and Quality teams. You'll be part of a fast‑moving environment where your contributions have immediate impact. The company offers 3 weeks of PTO and 10 paid holidays . Job Type & Location This is a Contract position based out of Irvine, CA. Pay and Benefits The pay range for this position is $40.00 - $55.00/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 Irvine,CA.

Application Deadline This position is anticipated to close on Apr 16, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.