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Manager, Quality Management System

Job Description

The Quality Systems Manager will oversee the continued creation, implementation, maintenance, and improvement of the quality management system to support Magic Leap products. They will drive continuous improvement into the quality management system through audits, customer feedback, post-market surveillance, etc.

Responsibilities

• Expand, manage, and maintain QMS and corporate compliance training tools.
• Manage internal and external resources needed to implement and maintain QMS.
• Manage the selection and development of people, resources, and budgets necessary to perform the functions required of the QMS.
• Motivate and inspire a quality compliance culture across the organization.
• Build effective and sustainable cross functional relationships to continue optimization of QMS and corporate policies.
• Drive an environment of teamwork and open communication
• Manage, track and report QMS metrics.
• Act as SME for strategic QMS guidance including technical expertise and best practices.
• Regularly meet with internal staff regarding quality system suitability, sustainability, and effectiveness.
• Direct involvement in day to day QMS operations and support.
• Lead third party system inspections/audits and implement corrective/preventive action as needed.
• Facilitate and lead QMS management review meetings.
• Work with Human Resources to ensure comprehensive quality management system training to all Magic Leap employees.

Qualifications

• 5+ years of leadership experience directly related to quality system management.
• Strong working knowledge of quality management system requirements for medical devices (eg, Part 820, ISO 13485) as well as consumer (ISO 9001).
• Certified auditor for 21 CFR 820 / ISO 13485 is a plus but not required.
• Prior experience in creating and implementing a new quality management system for an organization.
• A working knowledge of quality improvement tools and techniques.
• Proficiency with MS and Google software applications.
• Demonstrated ability to write technical documents and familiarity with systems ensuring requirements consistency.
• Strong interpersonal, communication, analytical and complex problem-solving skills.
• The ability to develop partnerships and influence to develop a quality culture within the company.
• Ability to work independently and has strong team building skills.
• An understanding of the principles of proper configuration management and document control.
• Ability to work in a fast paced environment.

Education

• Bachelor’s degree or equivalent and 10+ years of experience in working with quality management systems

Additional Information