Quality Assurance Systems Analyst

1 week ago


Irvine, California, United States OrthAlign Inc. Full time
Position Overview

OrthAlign, Inc., a leader in innovative medical technology, is seeking a Quality Systems Specialist to join our team. This role is pivotal in conducting thorough investigations into nonconformities and deviations within our quality management framework.

Key Responsibilities
  • Conduct comprehensive investigations to identify root causes of nonconforming products and conditions.
  • Oversee the Non-Conformance Management Report (NCMR) and Process Deviations processes, assisting stakeholders with containment strategies.
  • Manage and facilitate Corrective and Preventive Action (CAPA) processes from initiation to closure, ensuring effectiveness checks are completed.
  • Coordinate the CAPA program, guiding owners to meet process requirements and providing updates on overall performance.
  • Execute internal audits as per the established schedule and ensure all findings are tracked to resolution.
  • Contribute to the development and revision of Standard Operating Procedures (SOPs) to maintain compliance with quality standards.
  • Create and manage deviations, change orders, and CAPA documentation within the Quality Management System (QMS).
  • Assist in external audit preparations and support internal customers with the electronic Quality Management System.
  • Provide training for new users on system functionalities and manage access permissions.
  • Collaborate with IT to validate system updates and changes.
  • Support the Document Control Specialist by managing document and part number assignments and processing change orders.
Qualifications
  • Bachelor's degree with a minimum of 3 years of experience in the medical device quality or operations sector; 6 years of experience without a degree.
  • Proficient in Microsoft Office 365 applications and PDF software.
  • Strong knowledge of FDA regulations 21CFR820 and 13485:2016.
  • Certification as a medical device auditor or equivalent experience is preferred.
  • Ability to interpret and adhere to SOPs and cGMP regulations.
  • Exceptional organizational skills with the ability to prioritize tasks effectively while maintaining accuracy.
  • Strong written and verbal communication skills.
  • Interpersonal skills to engage effectively with both management and staff.
  • Experience in conducting root cause analysis.
  • Familiarity with quality assurance processes and tools, including flow charts and fishbone diagrams.
  • Experience with electronic quality management systems and document management systems.
What We Offer
  • Competitive salary with bonus and equity opportunities.
  • Career advancement potential.
  • Comprehensive benefits package.
  • A dynamic and engaging workplace culture.

Join OrthAlign and contribute to our mission of advancing medical technology.



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