Capstan Medical, Inc.
Document Control Specialist
Santa Cruz, California
Sponsorship not specifiedDetected 6 days ago
RoboticsMedical DevicesCommunicationWritingMicrosoft OfficeSharePoint
About the role
- Our team combines surgical robotics, catheter-based delivery, and next-generation implants to transform complex procedures into safer, lower-stress solutions for patients and clinicians alike.
- As a highly collaborative, hands-on team, we move fast, wear multiple hats, and believe the best ideas can come from anyone.
- Based in Santa Cruz, our unique workspace blends cutting-edge Bay Area innovation with a lifestyle-driven environment near trails, beaches, and open space-creating the perfect place to do meaningful, career-defining work.
Responsibilities
- Manage document workflows within the electronic document control system (Propel), including document creation, revision routing, approval, release, and obsolescence.
- Track and support change orders from creation through release; follow up with owners and approvers to maintain timely execution.
- Support creation, revision, formatting, routing, and periodic review of controlled documents, including work instructions (WIs), SOPs, forms, and templates related to the Document Control function.
- Partner with Quality and cross-functional subject matter experts to draft, edit, and update WI/SOP content, ensure alignment with current practices, and coordinate training impact assessment as applicable.
- Create and execute training programs and maintain training records for all employees.
- Manage and maintain the in-house electronic Standards library for controlled external standards, including indexing, controlled access, version/revision status, renewal or availability tracking, and communication of updates to affected stakeholders.
- Organize and maintain Quality Records within the SharePoint records repository, including folder structure, naming conventions, indexing/metadata, retention support, and general record completeness and traceability.
- Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings.
- Support quality system process metrics and document control improvement activities.
- Provide ancillary QA support, as needed, for Device History Record (DHR) and Nonconformance Report (NCR) reviews, including documentation completeness checks, records retrieval, routing support, and follow-up on documentation gaps.
Requirements
- Experience working within quality processes governed by regulatory standards, including 21 CFR Part 820/QMSR and ISO 13485.
- Experience drafting, revising, or maintaining quality procedures, WIs, SOPs, forms, and templates.
Nice to have
- Experience maintaining or administering an electronic Standards library is preferred.
- experience using Propel eQMS is preferred.
- Familiarity with Good Documentation Practices, quality record requirements, DHR documentation, and NCR processes is preferred.
- Experience with key systems such as Microsoft Office and ePLM/eQMS systems
Skills
- Proficiency with Microsoft Office applications and familiarity with SharePoint-based records organization.
- Detail-oriented, collaborative, proactive, and comfortable communicating with cross-functional teams.
Benefits
- We offer a fun, hands-on, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
- We offer projects and training to continue your learning and technical growth.
- We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
Equal opportunity
- We are an equal opportunity employer.
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