Senior Quality Manager

Responsibilities

• Drive the development, implementation, and improvement of Operation Quality Systems.
• Manage the Quality Engineering team, including Quality Engineers, Quality Control Supervisors, and Document Control Supervisors.
• Analyze Quality Systems data to identify trends and make recommendations for strategic objectives.
• Act as a technical advisor on all Quality Systems matters.
• Own and direct internal/external audits and supplier controls.
• Establish and monitor goals and metrics related to people, processes, and products.
• Plan and organize training activities and site-level Management Reviews.
• Facilitate and respond to supplier and customer quality surveys (REACH, RoHS, etc.).

Requirements

• Bachelor's degree.
• 10+ years of experience in Quality Management (including both Quality Assurance and Quality Control).
• 5+ years of experience in people management.
• 5+ years of experience in FDA Medical Device manufacturing.
• Mastery of ISO 13485 and proficiency in FDA 21 CFR Part 820.
• Experience with ISO 14971 Medical Device Risk Management.
• Proficiency with MS Office products.

Preferred Qualifications

• Quality Certifications such as Six Sigma Black Belt or Green Belt.
• Experience with Quality and Customer Audits.
• Experience with EQMS and MSA.
• Advanced Degree.

Benefits

• Competitive salary with a 15% performance-based bonus plan.
• 401(k) match and Age-Weighted Defined Contribution.
• Comprehensive medical, dental, and vision coverage.
• Health Savings Account (HSA) options.
• Paid holidays, vacation, and parental leave.
• Learning and professional development opportunities.

About the Company

Lubrizol Corporation, a Berkshire Hathaway company, is a global leader in specialty chemicals and medical solutions. For nearly 100 years, we have used science and innovation to enhance mobility, improve wellbeing, and advance modern life through products ranging from performance coatings to medical devices.