Функция: Отдел операций

Тип занятости: Полный рабочий день

Место расположения: Washington - Redmond

Страна: USA

  

SUMMARY

This position is responsible for the Clarisonic and LOBD (L'Oreal Beauty Devices) quality management system (QMS).  The role will work cross-functionally to establish and maintain an ISO 9001 and/or 13485 QMS for all and operations activities.  The position is also responsible for the configuration management system and leading field reliability tracking efforts.    

 

REPORTING – Reports to the Director, Industrial Quality

 

DUTIES AND RESPONSIBILITIES

  • Primary owner for the Quality Management System (QMS).
    • Work with internal organization to achieve ISO9001 and/or 3485 certifications and enable FDA compliance.
    • After certification, provide effective leadership, training and guidance to maintain certification. This includes creating and maintaining an internal auditing system.
    • Facilitate/Lead critical QMS activities such as Corrective and Preventive Action (CAPA), internal auditing, and Management Review.
  • Lead the Configuration Management and Document Control process.  Details include:
    • Own and maintain all procedures, systems, and database associated with configuration management and document control.   Current configuration management tool is Omnify.   
    • Work cross-functionally with product development and operations teams to ensure bill-of-material (BOM) and documentation associated with new releases and changes are properly managed.    
    • Ensure all documentation is adequately stored and controlled.
    • Work with supply chain personnel to implement product changes into the corporate ERP system and maintain proper life cycle status/control.  This position serves as the primary conduit for transfer of documentation and document changes to manufacturing partners.
    • Facilitate the deviation process.
  • Responsible for US and international field reliability tracking and related product quality investigations.  By working with data analyst and technicians, coordinate field failure and failure mode KPIs and CAPA.    
  • Develop, mentor, and manage QA personnel and promote quality culture. 
 

QUALIFICATIONS

  • BA/BS undergraduate degree in life sciences or engineering.   
  • 5+ years quality professional. Knowledge of ISO (9001 and or 13485) and FDA QMS requirements in a device development and operations environment. 3+ years Medical Device experience desired. 
  • Intimate knowledge with Configuration Management and Document Control systems, strategies, and tools/databases such as Agile or Omnify.
  • Experience with all phases of device product development lifecycle, including concept, design, implementation, and obsolete/end-of-life.   
  • Excellent interpersonal communications and presentation skills.
  • Ability to develop and manage a high performance team focused on accountability and meeting and exceeding expectations.
  • Independent and self-motivated.  Ability to lead, influence and work within cross-functional team environments.
  • Some international travel required.


We are an Equal Opportunity Employer and take pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.