Senior Document Control Coordinator

Senior Document Control Coordinator

Leading medical device company looking for an experienced Senior Document Control Coordinator. Ideal candidates should have a Bachelors degree with 36+ years of experience in quality systems, regulatory, or compliance roles within a regulated industry. As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance, Document Control).

Responsibilities

• Coordinate Change Control, Nonconformance, and CAPA workflows to ensure timely progression, closure, and compliance.
• Monitor record status, identify bottlenecks, and proactively drive actions to meet integration timelines.
• Facilitate cross-functional alignment to ensure completeness, accuracy, and consistency of quality records.
• Ensure downstream impacts (e.g., document updates, training, implementation activities) are identified and tracked.
• Develop and communicate summaries, dashboards, and status updates to stakeholders and leadership.
• Draw conclusions on overall system health and recommend targeted actions.
• Schedule and lead recurring and ad hoc meetings to drive progress, remove barriers, and ensure accountability.
• Identify and escalate risks, delays, or compliance concerns in a timely and structured manner.
• Manage document control activities, including document creation, review, approval, and lifecycle management.
• Serve as SharePoint administrator to maintain document repositories, permissions, and structure.
• Ensure document organization supports accessibility, traceability, and compliance requirements.
• Support migration and harmonization of documents as part of integration activities.

Requirements

• Bachelor's degree in science, engineering, business, or related discipline preferred.
• 36+ years of experience in quality systems, regulatory, or compliance roles within a regulated industry.
• Working knowledge of quality system processes (Change Control, CAPA, Nonconformance, Document Control).
• Strong ability to assess process performance, identify gaps, and drive improvements.
• Proficient in Microsoft Office tools, including Teams, SharePoint, Excel, PowerPoint, and Word.
• Experience using SharePoint as a document management platform (including administration and maintenance).
• Ability to work flexible hours to accommodate German time zones.