Senior Director Quality Vision Equipment

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 MedTech, 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. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Multi-Family Quality

Job Category:

People Leader

All Job Posting Locations:

Irvine, California, United States of America, Milpitas, California, United States of America

Job Description:

The Sr. Director Quality Vision Equipment, is accountable for overall strategy, execution and oversight of new product design control and validation, product stewardship, risk management, product quality improvements, quality management systems, and regulatory compliance for J&J Surgical Vision sites that develop, validate, and produce Surgical Vision equipment and consumables associated with equipment, to achieve sustained business results relative to regulatory outcomes and product quality. This role reports to the VP Quality and Compliance, J&J Vision and is located in Milpitas California.

Assure compliance with the applicable regulations such as, but not limited to, FDA Quality system Regulation 21 CFR Parts 820; ISO 13485, Current Good Manufacturing Practice (CGMP) regulation 21 CFR 210/211, and international regulatory requirements (Japanese MHLW, Brazilian ANVISA) for the company's products.

Acts as a strategic partner with business leaders in the development of the segment business strategy, compliance strategy, and effectively links the Quality objectives to the business strategy and results.

Directly accountable for business results within J&J Surgical Vision.

Manages quality, safety, and compliance escalation process within J&J Surgical Vision.

Functional accountability includes execution of Quality Management Systems, Q&C Metrics, CAPA management, Document Control, Change Control, Records Management, IT Quality Systems, Quality Planning, Risk Management and Training, as applicable for each J&J Equipment Surgical Vision site.  In addition, the function is responsible for new product design control and validation, product stewardship, product quality improvements, risk management and product measurement technologies. In this role is accountable for product quality improvements strategy for the life-cycle of product. This includes the flawless validation of new products. Further in the lifecycle, long standing brands will have a product quality end-to-end plan to be developed and executed in very strong collaboration with R&D and Supply Chain.

The Sr. Director must have an in-depth technical understanding of all product lines to be applied to charter, prototype and execute product introduction, measurement and changes. Strong scientific approach as well as rigorous problem solving methodology should be fostered in the organization. The incumbent should be at ease interfacing with, and leading Subject Matter Experts in equipment design, process, polymer science, optics, validation and inspection technologies.

The Sr. Director must be able to function as both an individual contributor and an overall director of activities in a matrixed organization. Ability to handle a variety of individual projects, while directing the efforts of direct reports at the same time.

The candidate will develop, improve and maintain an efficient and diverse team capable of executing the improvement cycles and new product validations using the above steps.

Accountable for J&J Vision Surgical Equipment, NPI, risk management, Quality Operations, and lifecycle management budget and strategic plan. Develops, reviews, approves and manages the Quality business plans, along with the appropriate human resources utilization.  Analyzes budgets and processes to maintain and enhance lean operations.

Oversees and leads site remediation plans, as necessary and as needed.

Maintains, sustai