Senior Manager, Product Quality Management

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Function:
Quality Job Sub Function:
Quality Assurance Job Category:
Professional All Job Posting Locations:
Irvine, California, United States of America, Milpitas, California, United States of America

Johnson & Johnson Vision, a member of the Johnson & Johnson family of companies, is recruiting for a Senior Manager, Product Quality Management located in Irvine, CA (Preferred) or Milpitas, CA. About Med Tech Fueled  by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness.

Partnership with Supply Chain (Ops, Value stream), R&D, QA, and commercial leadership, this position leads the monitoring, analysis and improvement of all aspects of brand quality from NPI through to the customer and communicates back to commercial on the brand health to improve brand equity. In parallel to the field performance, work with regulatory and quality systems both at an operating company level and an enterprise level, to look at the health authorities’ compliance landscape and incorporate proactively in the improvement strategy.

As a result, the position leads the strategic 10-year overview quality plan per brand addressing patient needs, using a combination of new product and improvement approaches.

• Partner with commercial organization, regional offices, Regulatory and Complaint handling to gather all short- and long-term information on the brands as they relate to performance in the field
• For new products, partner with R&D leadership to modify the new product development to optimize product quality. Position has the accountability to assess these launches as they relate to Product quality and has the scope to accelerate, modify or delay new product launches
• For existing products, partner with Supply Chain Leadership to assess and implement modifications to the manufacturing processes and lead the strategy of manufacturing improvements as they relate to product quality

In order to execute the strategy, the position relies on two Engineering groups who are dedicated to the Product Improvements: NPI Quality Engineering and Customer Experience Engineering. These groups represent over 20 engineers. They conduct the technology research and implementation of the strategy led by Product Quality Management in synch with R&D and Supply chain engineering.

• Accountable and signatory for quality plans, control plans, major changes and validations
• Responsible for communicating to all levels of the organization and integrating the brand quality plan into the overall product value stream with specific and quantifiable business outcomes
• This position is measured by the brand scorecard health which includes internal Quality metrics (NCs, Quality events), external Quality metrics (such as Customer complaints), Supply chain metrics (such as COGS) and Commercial metrics (such as adherence to BP)
• Adheres to environmental policy and procedures and supports department environmental objectives

• University / Bachelor’s Degree or equivalent is required. Bachelor’s Degree or equivalent in Statistics/Engineering/Science or Technical/MBA Degree or equivalent is preferred

• 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
• Demonstrate…