Quality Documentation Specialist

Capstan Medical Inc.; Santa Cruz (CA); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Flexible time off

Bike-friendly environment and team out

Job summary

Capstan Medical in Santa Cruz is seeking a QA Document Control Specialist to manage document workflows, change orders, and controlled records within Propel eQMS and SharePoint.

You will draft and revise WIs and SOPs, support audits, train staff, and maintain the standards library while collaborating with cross-functional teams in a fast-paced medtech environment.

The role offers growth opportunities and a culture that blends innovation with work-life balance near trails and beaches.

Qualifications

• BA/BS with 3+ years in a regulated healthcare industry (medical device, biopharma, diagnostics).
• Experience with 21 CFR Part 820/QMSR and ISO 13485.
• Experience drafting, revising, or maintaining quality procedures, WIs, SOPs, forms, and templates.
• Experience organizing electronic records repositories, preferably SharePoint.
• Strong technical writing, editing, proofreading and formatting skills for controlled documents.

Responsibilities

• Manage document workflows within Propel eQMS, including creation, revision routing, approval, release, and obsolescence.
• Track and support change orders from creation through release with owners and approvers.
• Support creation, revision, formatting, routing, and periodic review of WIs, SOPs, forms, and templates.
• Draft, edit, and update WI/SOP content in collaboration with QA and cross-functional SMEs.
• Create and execute training programs and maintain training records for all employees.
• Maintain in-house electronic Standards library with indexing and version control.
• Organize and maintain Quality Records in SharePoint with metadata and retention.
• Support internal and external audits and implement audit findings.
• Assist with quality system metrics and document control improvement activities.

Skills

Microsoft Office

SharePoint

eQMS/Propel

Technical writing

Documentation practices

Audits

Cross-functional communication

Education

Bachelor's degree

Tools

Propel eQMS

ePLM

SharePoint

Microsoft Office

Job description

Capstan Medical in Santa Cruz is seeking a QA Document Control Specialist to manage document workflows, change orders, and controlled records within Propel eQMS and SharePoint.

You will draft and revise WIs and SOPs, support audits, train staff, and maintain the standards library while collaborating with cross-functional teams in a fast-paced medtech environment.

The role offers growth opportunities and a culture that blends innovation with work-life balance near trails and beaches.