QMS Supervisor

About the role

Shape the Future with Us. At Lubrizol, 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.

Responsibilities

• 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.
• Accountable to conform and comply with all HSES policies and procedures.

Requirements

• 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

Qualifications

Required qualifications that enables your success include:

• 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

Skills

• Strong leadership and management skills.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively with cross-functional teams.
• Proven ability to lead and manage audit programs.
• Experience with regulatory compliance and industry standards.
• Effective training and development capabilities.
• Strong problem-solving and decision-making abilities.

Benefits

• 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.

Pay

$120,000 - $125,000 plus 6% bonus.

Schedule

Full Time / On_site