QMS Supervisor

Job Type: Full Time / On site

Salary Range: $120,000 - $125,000 plus 6% bonus

As a Quality Management System Supervisor
, you’ll be at the forefront of our innovation and excellence by driving Quality Management Systems activities, including internal audits and management review programs. You’ll collaborate with a diverse group of passionate individuals to deliver sustainable solutions to advance mobility, improve wellbeing, and enhance modern life. In this role, you will:

• Be responsible and accountable for all site QMS activities to be executed promptly and effectively.
• Establish and sustain the site QMS in line with the required industry standards (e.g., FDA 21
  
  CFR 820, ISO 13485, ISO 14001 / ISO 9001 / ISO 45001).
• Lead and manage the audit program and ensure that all nonconformities raised during audits are effectively corrected and independently verified.
• Lead and manage customer audits at the site.
• Manage all external registration requirements to ensure they are met. Liaise with external entities on all matters relating to registration.
• Ensure training for the Quality Management System is effective.
• Ensure internal audits of the QMS are process-based per the audit plan and effective.
• Develop, implement, and manage key leading / lagging performance indicators (KPIs) related to the QMS.
• Ensure all required inputs for the Management Review Meeting (MRM) are reviewed/assessed.
• Work as part of the Management team to share ideas and improve operations, recommending, supporting, and implementing continuous improvement activities for the QMS.
• Be responsible for the quality training program.
• Be accountable to conform and comply with all HSES policies and procedures.

• Bachelor’s degree from an accredited university.
• 5+ years experience leading a QMS within a regulated manufacturing industry (medical devices preferred).
• 5+ years of demonstrated leadership experience leading/managing cross-functional teams.
• 5+ years of experience managing others.
• Experience leading audit programs.
• Experience as an internal and external liaison on quality needs.
• Familiarity with ISO 13485 and 21 CFR 820.

• Standing, walking, or operating equipment for extended periods.
• Working in a lab or manufacturing setting with appropriate PPE provided.
• Use of computers and digital tools in an office or hybrid environment.
• Occasional lifting or movement of materials.
• Adherence to rigorous safety protocols and ergonomic standards.

• Competitive salary with performance-based bonus plans.
• 401(k) match + Age-Weighted Defined Contribution.
• Health Savings Account (HSA).
• Paid holidays, vacation, and parental leave.