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.