Quality & Document Control Specialist | Unlimited PTO

Carlsmed, Inc.; Carlsbad (CA); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Medical benefits

401(k) match

Unlimited PTO

Annual bonuses

Job summary

Carlsmed, Inc. is seeking a Quality Assurance Specialist to administer document control within the QMS. You will manage controlled documents, Arena administration, and training records while supporting QA activities and collaborating with process owners and approvers.

This individual contributor role emphasizes keeping information current, traceability of changes, and retrievable records. You will participate in audits, improve workflows, and help ensure compliance with ISO 13485 and FDA quality

Qualifications

• 7+ years in document control or QA within a regulated industry, preferably medical devices.
• Knowledge of controlled documents, change control, training records, and good documentation practices; familiarity with ISO 13485, FDA QSR, and MDSAP.
• Experience with an electronic QMS or PLM system; Arena experience preferred.
• 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.
• Experience supporting audits and electronic system changes; BarTender or similar labeling systems is beneficial.

Responsibilities

• Process documents and change orders with verification of details, records, and approvals before release.
• Coordinate document creation, revision, approval, distribution, and archival with effective dates and training actions.
• Review documents for format, completeness, consistency, and cross-references; resolve discrepancies with owners.
• Maintain controlled documents and records at points of use and manage superseded versions.
• Administer Arena templates, workflows, attributes, and user access; provide user support.
• Import and verify master data; maintain traceability of corrections and data integrity.
• Support training administration, track completion, and report training status.
• Maintain quality records and prepare for audits; ensure retrieval for inspections.
• Support QA records, labeling templates, and device identifier records per procedures.

Skills

Attention to detail

Strong communication

Coordination across teams

Tools

Arena

Microsoft Office

BarTender

Job description

Carlsmed, Inc. is seeking a Quality Assurance Specialist to administer document control within the QMS. You will manage controlled documents, Arena administration, and training records while supporting QA activities and collaborating with process owners and approvers.

This individual contributor role emphasizes keeping information current, traceability of changes, and retrievable records. You will participate in audits, improve workflows, and help ensure compliance with ISO 13485 and FDA quality