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Document Control Analysts Ii

3 months ago

Pleasanton, United States Noctrix Health, Inc. Full time

Noctrix Health is a privately held, VC-backed, emerging growth medical device company whose vision is to
develop clinically validated ‘therapeutic wearables’ that allow for medical devices to become a true alternative to
pharmaceuticals in the management of chronic neurological disorders. The Company was originally spun off from
the prestigious Stanford Biodesign Fellowship
- one of the country’s best medical device innovation programs that
has generated over 50 medical device companies to date with technology that has directly impacted over 2.7million
patient lives. The Noctrix Health team is a mix of medical device experts working shoulder to shoulder with
neuroscientists and engineers from the consumer electronics world to deliver a prescription-grade therapy with an
outstanding user experience.

Document Control Analysts II

GENERAL DESCRIPTION
The Document Control Analysts II at Noctrix Health is responsible for ensuring the Noctrix
Health Document Control System is managed in compliance with Noctrix Health’s SOPs. The
Document Control Analysts II will be based at Noctrix Health’s Pleasanton, CA location. This
position is responsible for managing and administering the Noctrix eQMS Document Control
systems to ensure compliance to applicable internal procedures, medical device GMPs, and
regulatory requirements.
This position will also be responsible for managing and maintaining the Noctrix Health
training program related to the controlled documents and internal training. Additional functions
include QA support for change control, document control, training, eQMS validation, audits,
and regulatory inspections.
This position reports to Sr. Director Quality Assurance
FUNCTIONS
- Serves as primary Document Control/eQMS administrator
- Works independently to manage and administer effective Document Control systems

ensuring compliance to applicable internal procedures and applicable regulatory
requirements
- Works with QA Director to establish and execute Document Control Procedures
- Supports update, review, and approval of controlled documents, including standard

operating procedures, standard test methods, protocols, reports, and technical documents
according to specific approved formats
- Creates and maintains document templates as needed
- Ensures controlled documents conform with applicable procedures, reviews formats for

consistency
- Supports controlled document life cycle/retention procedures
- Manages employee training program and periodic review of all electronic training files
- Updates Training Matrices for all GMP employees; creates and maintains electronic

employee training files; assists with group training
- Assists with Supplier Management Program - maintains database and tracks due dates for

audit reports, supplier re-assessments
- Manages Records Retention/Archiving, ensuring adherence to record retention schedules
- Writes QMS SOPs related to document control/document management and other QMS

areas as needed
- Assists with audits and regulatory inspections
- Provides cross-functional support within QA department, as needed
- Perform other QA related duties as assigned by QA Director
- Follows Noctrix procedures, policies, and applicable regulations