Jobs in Santa Cruz, CA

About the role

This role is for the Capstan Medical Quality Assurance Department.

What you'll bring

• 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
• · Experience with key systems such as Microsoft Office and ePLM/eQMS systems
• · Flexible and comfortable in a fast-paced work environment.
• · Experience maintaining or administering an electronic Standards library is preferred.
• · Familiarity with Good Documentation Practices, quality record requirements, DHR documentation, and NCR processes is preferred.
• preferably SharePoint, with an emphasis on file structure, naming conventions, indexing/metadata, access coordination, and retention support.
• experience using Propel eQMS is preferred.