QA & Document Control Specialist | Medical Devices

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

Benefits offered by this job

Medical insurance (100% employer-paid)

Dental insurance (100% employer-paid)

Vision insurance (100% employer-paid)

401(k) plan with employer matching

Unlimited PTO

Job summary

Carlsmed, Inc. is seeking a Quality Assurance Specialist to manage document control within the QMS. The role focuses on controlled documents, Arena administration, training records, and QA support with process owners and approvers.

Responsibilities include handling change orders, maintaining records, and ensuring traceability and compliance with regulatory requirements. The ideal candidate has 7+ years in document control or QA in regulated industries and strong attention to detail.

Qualifications

• 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; 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 and escalated missing evidence or overdue work.
• Experience supporting audits and electronic system changes preferred; BarTender or other controlled labeling system experience is beneficial.

Responsibilities

• Process document and engineering change orders, verifying document details 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, ensuring current revisions are available at points of use.
• Administer Arena templates, workflows, attributes, and user access under change controls; provide user support.
• Import and verify approved master data, ensure traceability of corrections and resolve discrepancies.
• Support change assessments and validation through checks, documented results, and evidence approved before implementation.
• Onboard employees into the QMS and assign training; track completion and escalated gaps to managers.
• Maintain training records and report training status; guide employees on document control procedures.
• Maintain quality records, retrieve documents for audits, and archive approved records.

Skills

Document control

QA in regulated industry

Arena experience

ISO 13485 knowledge

Microsoft Office

Attention to detail

Cross-functional coordination

Audit support

Tools

Arena

Job description

Carlsmed, Inc. is seeking a Quality Assurance Specialist to manage document control within the QMS. The role focuses on controlled documents, Arena administration, training records, and QA support with process owners and approvers.

Responsibilities include handling change orders, maintaining records, and ensuring traceability and compliance with regulatory requirements. The ideal candidate has 7+ years in document control or QA in regulated industries and strong attention to detail.