Quality Systems Specialist

4 weeks ago

Irvine, California, United States OrthAlign Full time
Job Title: Quality Systems Specialist

OrthAlign, Inc., a leading medical device company, is seeking a highly skilled Quality Systems Specialist to join our team. This role is responsible for ensuring the effective establishment and implementation of our quality management system, meeting the needs of our customers, and fulfilling global medical device regulations and standards.

Key Responsibilities:
  • Perform robust investigations to determine root causes for deviating conditions or nonconforming materials or 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:
  • With your BA/BS degree, 3+ years of experience, without degree, 6 years, 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.
  • 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.

It is an exciting time at OrthAlign - make your next career move with us. Please note that we are unable to provide any type of sponsorship at this time. No recruiters, please.

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