Quality Systems Specialist: Documentation & Compliance

Sanisure Llc

Camarillo (CA)

On-site

USD 70,000 - 75,000

Full time

9 days ago
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Job summary

SaniSure is seeking a Quality Systems Specialist to support and maintain the Quality Management System in Camarillo, CA. You will oversee creation, review, and controlled release of quality and technical documentation including SOPs, specifications, and validation data.

The role works cross-functionally with Quality, Engineering, R&D/NPI, Regulatory Compliance, Manufacturing, and Supply Chain to ensure accurate, traceable, and compliant product information throughout the lifecycle.

Qualifications

  • 3+ years' experience in quality systems within regulated manufacturing.
  • Experience with risk management tools (FMEA) and CAPA methods.
  • Knowledge of QMS and document-control practices.
  • Experience creating, reviewing, and maintaining controlled documents.
  • Ability to interpret drawings, specs, and component information.
  • Experience with supplier qualification and quality improvements.

Responsibilities

  • Develop, review, approve, and maintain quality documentation and records.
  • Coordinate collection of product/component information including specs and compliance data.
  • Maintain revision history, traceability, and controlled release processes.
  • Support internal/supplier audits and CAPA activities.
  • Monitor quality trends and drive improvements across the QMS.

Skills

Quality systems
Documentation control
CAPA/root cause
FMEA
QMS principles
Document-control practices
Audits
Technical documentation
Supplier qualification
Detail oriented

Education

Bachelor's degree in biological sciences, engineering, or related field

Job description

SaniSure is seeking a Quality Systems Specialist to support and maintain the Quality Management System in Camarillo, CA. You will oversee creation, review, and controlled release of quality and technical documentation including SOPs, specifications, and validation data.

The role works cross-functionally with Quality, Engineering, R&D/NPI, Regulatory Compliance, Manufacturing, and Supply Chain to ensure accurate, traceable, and compliant product information throughout the lifecycle.

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