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Magic Leap // augmented reality tech
 
Plantation, FL    Posted: Monday, May 16, 2022
 
   
 
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JOB DETAILS
 
Job Description

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

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

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

Responsibilities:

  • Ability to work cross-functionally throughout the entire organization. 
  • Assist in the creation, implementation & maintenance of quality system procedures. 
  • Motivate & inspire a quality system/compliance culture across the organization
  • Build effective & sustainable cross functional relationships
  • Drive an environment of teamwork & open communication
  • Act as SME for strategic QMS guidance including technical expertise in the areas of configuration management, change control & traceable product life cycles. 
  • Regularly meet with internal staff regarding quality system suitability & effectiveness. 
  • Direct involvement in day to day QMS operations.  
  • Provides input & lead users in the effective & 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 & 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 & Google software applications.
  • Demonstrated ability to write technical documents.
  • Strong interpersonal, communication, analytical & complex problem solving skills.
  • The ability to develop sustainable partnerships & influence culture.
  • Ability to work independently. 
  • Strong leadership & team building skills.
  • Adaptability to changing & growing job requirements Strong attention to detail, the ability to multi-task & stay organized in a fast paced & changing environment. 
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