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Salary: USD 85,000 - 95,000 / annual
Carlsmed is a medical device company focused on improving outcomes and reducing costs in spine surgery through its aprevo® personalized surgery platform.
The Quality Assurance Specialist administers document control and quality records within the Quality Management System (QMS). This individual contributor role supports QA's mission to define, maintain, and improve the QMS by keeping approved information current, changes traceable, and records complete and retrievable.
Key responsibilities include:
**Controlled Documents & Change Orders:** Process document and engineering change orders with verification of details, supporting records, and approvals before release. Coordinate document creation, revision, approval, distribution, and archival. Review documents for format, completeness, consistency, and cross-references. Maintain controlled documents and records, ensuring current revisions are available at points of use.
**Arena Administration & Data Integrity:** Administer Arena templates, workflows, attributes, and authorized user access under approved change controls. Import and verify approved master data, resolve discrepancies, and maintain traceability of corrections. Support change assessments and validation through assigned checks and documented results.
**Training Administration & User Support:** Onboard employees into the QMS and assign training using approved role requirements and curricula. 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.
**Quality Records & Audit Support:** Maintain quality records under approved access, confidentiality, and retention requirements. Retrieve documents and evidence for audits and inspections. Check assigned QA records for completeness and required approvals. Maintain supplier and QMS files, track documentation due dates. Support controlled label templates and BarTender administration. Identify recurring errors and recommend improvements to workflows.
**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; 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 escalate missing evidence or overdue work
- Experience supporting audits and electronic system changes preferred
- BarTender or other controlled labeling system experience beneficial
