Quality Management System Supervisor
amtexenterprises.com
Job at a glance
Job Title : Quality Management System Supervisor Salary Range: $120-125K with a 6% bonus. Location: Corona, CA The role is 100% on-site and the client prefers candidates from California. About the job Shape the Future with Us. We’re transforming the Specialty Chemical and Medical Solutions industries through science, sustainability, and a culture of inclusion. As part of our global team, you’ll be empowered to make a real impact—on your career, your community, and the world around you.
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 21CFR 820, ISO13485, ISO14001 / ISO 9001 / ISO45001). • 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 that they are 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 operation, 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. Required Qualifications That Enables Your Success • 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 the ISO 13485 and 21 CFR 820 Your Work Environment Role We’re committed to providing a safe, inclusive, and empowering environment where you can do your best work—whether in a lab, on the production floor, or in a hybrid office setting.
Depending on your role, your work environment may include: • 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 • [add site/role specific] We continuously invest in our facilities and technologies to ensure they support your well-being, productivity, and growth.
If you require reasonable accommodation, we are committed to working with you to ensure an inclusive and accessible experience. Benefits that Empower You • Competitive salary with performance-based bonus plans • 401(k) match + Age-Weighted Defined Contribution • Comprehensive medical, dental & vision coverage • Health Savings Account (HSA) • Paid holidays, vacation, and parental leave • Flexible work environment • Learning and development opportunities • Career and professional growth • Inclusive culture and vibrant community engagement Interested candidates send your resume to [email protected]