Doc Control Specialist

Document Control Specialist

We are seeking an experienced Document Control Specialist to support a medical device organization undergoing post-merger integration and remediation activities. This onsite role in Irvine, CA is critical to ensuring documentation integrity, compliance, and consistency across legacy and newly integrated quality systems. The ideal candidate brings hands-on experience with engineering change processes, strong quality judgment, and the confidence to push back on incomplete or non-compliant submissions while working closely with Engineering and Quality teams in person.

Responsibilities:

• Manage and process Engineering Change Orders (ECOs), document change requests, and related quality records in compliance with FDA and ISO requirements.
• Review change packages for completeness, accuracy, and appropriateness of the selected change type.
• Ensure documentation meets quality standards, including correct pagination and formatting, required signatures and approvals, inclusion of all impacted documents, and alignment between change justification and scope.
• Push back on engineers and stakeholders onsite when submissions do not meet quality or procedural requirements, providing clear guidance on required corrections.
• Support documentation remediation efforts resulting from mergers and acquisitions, including harmonization of document formats, numbering systems, and procedures.
• Assist with document migration and integration activities while maintaining traceability and compliance.
• Identify documentation gaps or inconsistencies and support corrective actions in collaboration with onsite cross-functional teams.
• Update CAD-controlled documentation, including title block information on engineering drawings/prints, revision history, and metadata accuracy.
• Understand and support Bill of Materials (BOM) updates, ensuring 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, trackers, and support audits and inspections by retrieving documentation and explaining document control processes to auditors.

Essential Skills:

• 35 years of document control experience within the medical device industry.
• Strong knowledge of FDA Quality System Regulation (21 CFR 820) and ISO document and change control standards.
• Experience processing ECOs and document change orders.
• Demonstrated ability to enforce quality standards and challenge non-compliant documentation.
• Proficiency in Microsoft Word and PowerPoint, including controlled document formatting.
• Experience working with engineering drawings, CAD documentation, and BOMs.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities in a fast-paced onsite environment.

Additional Skills & Qualifications:

• Experience supporting M&A integration and remediation efforts.
• Familiarity with eQMS or PLM systems (e.g., Agile, Windchill, Arena, MasterControl).
• Strong interpersonal and communication skills for frequent onsite collaboration with Engineering, Quality, and Regulatory teams.

Work Environment:

This role is based onsite in Irvine, CA, and involves frequent collaboration with Engineering and Quality teams. The position requires strong attention to detail and the ability to manage multiple priorities in a fast-paced environment. The company offers 3 weeks of PTO and 10 paid holidays. Dress code and other specific work environment conditions are not specified.

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 Mar 10, 2026.