Hybrid Senior Manager, Product Quality Management

at OneTrust

• Job title: Senior Manager, Product Quality Management
• Job type: Full Time
• Experience level: Senior
• Salary: $122,000 - $212,750 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Irvine, United States

About the role

• Senior Manager leading product quality management for Johnson & Johnson Vision. Focusing on medical devices through data analytics and collaboration with cross-functional teams.

Responsibilities

• Lead the monitoring, analysis and improvement of all aspects of brand quality
• Partner with commercial organization, regional offices, Regulatory and Complaint handling
• Gather all short-and-long term information on the brands as they relate to performance
• Partner with R&D leadership to modify new product development to optimize product quality
• Assess new product launches as they relate to Product quality
• Partner with Supply Chain Leadership for existing products to implement modifications
• Lead strategy of manufacturing improvements as they relate to product quality
• Oversee CAPAs on the topic and account for short-term brand decisions
• Review and assess any brand-wide deviation from the design intent
• Responsible for communicating to all levels of the organization and integrating the brand quality plan into the overall product value stream

Requirements

• 8-10 years of experience in Medical Device Industry, Statistics or Process Engineering
• Excellent communication, interpersonal and organizational skills
• Understanding of the New Product Introduction (NPI) process
• Thorough understanding of GMP/ISO regulations, validation regulations
• Strong leadership, mentoring skills
• Demonstrated management abilities
• Demonstrated leadership ability over several functions
• Business sense and experience
• Able to build cost savings and growth business cases
• Preferred: 3+ years of experience in at least 2 of the 3 following domains: Quality, R&D & Manufacturing
• Understanding and application of principles, concepts and practices of statistical methods
• Excellent technical understanding of manufacturing equipment and processes
• Demonstrated experience in technical improvements process

Benefits

• medical, dental, vision, life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• vacation – up to 120 hours per calendar year
• sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• holiday pay, including Floating Holidays – up to 13 days per calendar year of Work
• Personal and Family Time - up to 40 hours per calendar year