Document Control Specialist

Capstan Medical, Inc.; Santa Cruz (CA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Flex time off

Collaborative team environment

Job summary

Capstan Medical, Inc. is seeking a Quality Assurance Document Control Specialist in Santa Cruz. You will manage document workflows, revisions, and training records within Propel eQMS and SharePoint, ensuring data integrity and compliance with 21 CFR Part 820 and ISO 13485.

You will partner with Quality and other functions to maintain SOPs/WIs, support audits, and drive continuous improvement in controlled documentation processes.

Qualifications

• Proficiency with Microsoft Office and SharePoint-based records organization.
• Experience using electronic document control, eQMS, ePLM, or records management systems.
• Strong technical writing, editing, proofreading, and document formatting for procedures, WIs, SOPs, and templates.

Responsibilities

• Manage document workflows in Propel eQMS: creation, routing, approval, release, obsolescence.
• Track and support change orders from creation to release with owners and approvers.
• Assist with creating, revising, formatting, routing, and reviewing WIs, SOPs, forms, and templates.
• Collaborate with Quality and cross-functional SMEs to draft and update WI/SOP content and coordinate training impact assessments.
• Create and execute training programs and maintain training records for all staff.
• Maintain in-house electronic Standards library with indexing, access controls, and version status.
• Organize Quality Records in SharePoint with clear structure, metadata, and retention.
• Support internal and external audits with documentation prep and evidence gathering.
• Contribute to quality system metrics and improvement activities.
• Provide QA support for Device History Records (DHR) and NCR reviews, including documentation gaps follow-up.

Skills

MS Office

SharePoint

eQMS/ePLM experience

Technical writing

Data integrity & traceability

Cross-functional communication

Education

BA/BS in a regulated healthcare field

Tools

Propel eQMS

Job description

At Capstan Medical, we’re building one of the most exciting and innovative companies in medtech—developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. 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.

This role is for the Capstan Medical Quality Assurance Department.

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!

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.