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Quality Systems Specialist

4 weeks ago

Irvine, California, United States OrthAlign Inc. Full time
Job Description

OrthAlign, Inc. is seeking a Quality Systems Specialist to support the effective establishment and implementation of the quality management system. The ideal candidate will have a strong understanding of FDA 21CFR820 and 13485:2016 regulations and experience in medical device quality and/or operations environment.

Key Responsibilities:

  • Perform root cause investigations into deviating conditions and nonconforming products.
  • Coordinate NCMR and Process Deviations processes by initiating and assisting owners with containment.
  • Manage, coordinate, and conduct CAPA activities from opening new CAPAs to closure and effectiveness check.
  • Coordinate the CAPA program, including guiding CAPA owners to ensure timely fulfillment of process requirements; compiling, analyzing, and communicating overall status of process performance.
  • Perform internal audits in accordance with internal audit schedule.
  • Track audit findings to completion.
  • Participate in authoring and/or revising Standard Operating Procedures (SOPs) to ensure compliance and quality objectives are met.
  • Create deviations, change orders, and CAPA records pertaining to their functional areas in QMS.
  • Support external audit activities (FDA, ISO registrar audits etc.).
  • Support internal customers with, and provide troubleshooting for, the electronic Quality Management System.
  • Train new users on the system functionality and grant system access to employees.
  • In cooperation with the IT function, validate system changes and updates.
  • Provide backup support to the Document Control Specialist. Assigns document and part numbers and processes change orders via QCBD.

Requirements:

  • Bachelor's degree in a related field or equivalent experience.
  • 3+ years of experience in medical device quality and/or operations environment.
  • Proficiency with Microsoft Office365 (Word, Excel, PowerPoint, Teams, SharePoint) and PDF software.
  • Strong understanding of FDA 21CFR820 and 13485:2016 regulations.
  • Certified medical device auditor or equivalent experience.
  • Ability to read, understand, and follow SOPs and comply with cGMPs.
  • Excellent organizational skills, ability to manage competing priorities, and the ability to maintain a high-level of accuracy.
  • Excellent written and verbal communication skills.
  • Interpersonal ability to effectively interact with management and staff.
  • Experience performing root cause analysis investigations.
  • Working knowledge of quality processes, procedures, and requirements.
  • Knowledge of quality tools such as flow charts, 5-why, cause maps, and fishbone diagrams.
  • Experience using an electronic quality management system (e.g., QCBD, EtQ, etc.) and electronic document management system/PLM (e.g., Oracle's Agile, Documentum, etc.).

We Offer:

  • Competitive compensation including bonus and equity.
  • Opportunities for career advancement.
  • Full benefits package.
  • An evolving, engaging culture and workplace.