Job Description

As the Sr. Quality Systems Specialist you will work with the Quality System Manager and various cross functional stakeholders to oversee the creation, implementation, and maintenance of an ISO 9001 Quality Management System designed to support Magic Leap’s enterprise and medtech products. 

The Sr, Specialist will begin by working with our Engineering and Manufacturing teams to document our current processes and advise the area’s stakeholders on how to achieve and maintain compliance to ISO 9001. 

The day to day work may include leading teams, providing training, acting as a subject matter expert and fielding questions or concerns from our leadership team. 

Responsibilities:

  • Ability to work cross-functionally throughout the entire organization. 
  • Assist in the creation, implementation and maintenance of quality system procedures. 
  • Motivate and inspire a quality system/compliance culture across the organization
  • Build effective and sustainable cross functional relationships
  • Drive an environment of teamwork and open communication
  • Act as SME for strategic QMS guidance including technical expertise in the areas of configuration management, change control and traceable product life cycles. 
  • Regularly meet with internal staff regarding quality system suitability and effectiveness. 
  • Direct involvement in day to day QMS operations.  
  • Provides input and lead users in the effective and compliant use of QMS applications.
  • Participate in internal or third party system inspections/audits
  • Ability to provide comprehensive Quality System Training to all employees.

Qualifications:

  • Experience with the creation of a QMS from scratch for a highly technical consumer products preferred. 
  • Working knowledge of quality system requirements for ISO 9001 including a solid understanding of configuration management and change control.
  • Exposure to medical devices eg, Part 820, ISO 13485, ISO 14971, MDR desirable. 
  • Current Lead Auditor Certification or the ability to achieve certification
  • Proficiency with MS and Google software applications.
  • Demonstrated ability to write technical documents.
  • Strong interpersonal, communication, analytical and complex problem solving skills.
  • The ability to develop sustainable partnerships and influence culture.
  • Ability to work independently. 
  • Strong leadership and team building skills.
  • Adaptability to changing and growing job requirements Strong attention to detail, the ability to multi-task and stay organized in a fast paced and changing environment. 

 Education:

  • Bachelor’s degree or equivalent and 5+ years of experience in working with quality management systems.

Additional Information

  • All your information will be kept confidential according to Equal Employment Opportunities guidelines.

 

 

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