Quality Assurance Specialist - Document Control

Carlsmed • Carlsbad, CA

4d • $85,000 - $95,000

About The Position

The Quality Assurance Specialist is an individual contributor who administers document control and related quality records within Carlsmed’s Quality Management System (QMS). The role supports the definition, maintenance, and improvement of the QMS by keeping approved information current, changes traceable, and records complete and retrievable. It focuses on controlled documents, Arena administration, training records, and documentation support for QA activities. The Specialist works with process owners and designated approvers and performs reviews or approvals within documented training and delegated authority.

Requirements

• 7+ years in document control or QA within a regulated industry, preferably medical devices.
• Working knowledge of controlled documents, change control, training records, and good documentation practices.
• Familiarity with ISO 13485, applicable FDA quality system requirements, and MDSAP.
• Experience with an electronic QMS or product lifecycle management system.
• Proficiency with Microsoft Office and accurate data entry and record retrieval.
• Strong attention to detail, organization, written communication, and follow-through.
• Ability to coordinate with multiple functions and escalate missing evidence or overdue work.

Nice To Haves

• Arena experience.
• Experience supporting audits and electronic system changes.
• BarTender or other controlled labeling system experience.

Responsibilities

• Process document and engineering change orders, verifying document details, supporting records, and approvals before release.
• Coordinate document creation, revision, approval, distribution, and archival, including effective dates and required implementation and training actions.
• Review documents for format, completeness, consistency, and cross-references, and resolve discrepancies with owners responsible for technical content and impact assessments.
• Maintain controlled documents and records, ensuring current revisions are available at points of use and superseded versions are controlled.
• Administer Arena templates, workflows, attributes, and authorized user access under approved change controls, and provide user support.
• Import and verify approved master data, resolve discrepancies, and maintain traceability of corrections.
• Support change assessments and validation through assigned checks, documented results, and evidence approved before implementation.
• Onboard employees into the QMS and assign training using approved role requirements and curricula, coordinating with managers responsible for role-specific competence.
• Maintain training records, track completion, follow up on overdue assignments, and escalate gaps to managers.
• Report training status and guide employees on document control procedures.
• Maintain quality records under approved access, confidentiality, and retention requirements, and retrieve documents and evidence for audits and inspections.
• Check assigned QA records for completeness and required approvals, return deficiencies to owners, and archive approved records, including patient-specific preproduction files and DHRs.
• Maintain supplier and other QMS files, track documentation due dates, and follow up with owners.
• Support controlled label templates, approved label data, assigned BarTender administration, and device identifier records under approved procedures.
• Identify recurring errors and recommend improvements to document control workflows and user guidance.

Benefits

• 100% employer-paid medical, dental, and vision insurance premiums.
• 401(k) plan with employer matching.
• Unlimited paid time off (PTO).
• Eligible employees may participate in incentive compensation programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed