The Quality Systems Manager will develop & sustain the Quality Management System in line with the required industry standards to include ISO 9001 accreditation requirements & the business requirements across the organization through existing & new procedures. Regulate, control & improve the quality of all processes throughout the business & the final product. Manage the audit program to ensure that all nonconformities raised are effectively corrected & independently verified. Embed a culture of continuous improvement throughout the company. Lead the team to achieve quality management system targets for customers & business goals.
The Quality Systems Manager is responsible for developing the QMS strategy, policies, processes, standards & systems for Magic Leap & its supply chain. This may include auditing to ensure compliance.
Expected to provide input into the department budget when appropriate & is responsible for ensuring changes are properly documented & implemented.
- Contribute to the creation & implementation of best practices, policies, processes & procedures to aid & improve operational performance
- Develop the Quality Management Systems strategy & key milestones, demonstrating solid progress against plan
- Contribute to new business initiatives & projects & review & communicate the impact on Quality Management Systems (QMS)
- Manage, coach & develop a high performing Quality System team that meets agreed objectives & which delivers best practice results, added value & continuous improvements
- Motivate & inspire a quality compliance culture across the organization
- Build effective & sustainable cross functional relationships
- Drive an environment of teamwork & open communication
- Ability to maintain a focused, target driven can-do attitude
- Track & report project metrics.
- Regularly meet with internal staff regarding quality system suitability & effectiveness.
- Direct involvement in day to day QMS operations
- Facilitate/Lead third party system inspections/audits & implement corrective/preventive action as needed
- Facilitate/Lead management review meetings
- With Human Resources, ensure comprehensive Quality System training provided to all employees.
- Train others in all aspects of the quality system & application of procedures
- 5+ years of leadership experience directly related to Quality System Management. A strong understanding of industry standard requirements.
- Strong working knowledge of quality system requirements for both consumer products (eg, ISO 9001) as well as medical devices (eg, Part 820, ISO 13485, ISO 14971, MDD, CMDR).
- Strong experience in building & implementing QMS for new companies
- A working knowledge of quality improvement tools & techniques.
- Proficiency with MS & Google software applications.
- Demonstrated ability to write technical documents.
- Strong interpersonal, communication, analytical & complex problem solving skills.
- Produce written reports & make presentations to Senior Leadership Team
- The ability to develop partnerships & influence.
- Ability to work independently & has strong team building skills.
- An understanding of the principles of proper configuration management & document control.
- Ability to work in fast paced environment