Document Control Specialist
Capstan Medical · Santa Cruz, California, United States · onsite
Description / Core 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.
- · Perform other quality responsibilities as assigned.
Skills:
- Proficiency with Microsoft Office applications and familiarity with SharePoint-based records organization.
- · Experience using electronic document control, eQMS, ePLM, or records management systems.
- · Strong technical writing, editing, proofreading, and document-formatting skills for controlled procedures, WIs, SOPs, forms, and templates.
- · Ability to interpret and organize controlled quality records while maintaining high attention to data integrity, traceability, and Good Documentation Practices.
- · Excellent organizational and prioritization skills with the ability to manage multiple documents, change orders, records, and stakeholder follow-ups independently.
- · Detail-oriented, collaborative, proactive, and comfortable communicating with cross-functional teams.
- · Ability to support audits, quality records requests, and issue-resolution follow-up in a regulated quality environment.
Requirements:
- BA/BS with 3+ years of work experience in a regulated healthcare industry segment (medical device, biopharma, diagnostics) in a document control, quality systems, or quality records role.
- · Experience working within quality processes governed by regulatory standards, including 21 CFR Part 820/QMSR and ISO 13485.
- · Demonstrated experience managing controlled documents through revision, approval, release, training, and archival/obsolescence workflows.
- · Experience drafting, revising, or maintaining quality procedures, WIs, SOPs, forms, and templates.
- · Experience organizing electronic records repositories, preferably SharePoint, with an emphasis on file structure, naming conventions, indexing/metadata, access coordination, and retention support.
- · Experience maintaining or administering an electronic Standards library is preferred.
- · Experience with key systems such as Microsoft Office and ePLM/eQMS systems; experience using Propel eQMS is preferred.
- · Familiarity with Good Documentation Practices, quality record requirements, DHR documentation, and NCR processes is preferred.
- · Flexible and comfortable in a fast-paced work environment.
Why Join Us:
- 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.
- We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!