Senior Director, Quality Vision Equipment

Role Overview

• 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, sustains and continuously improves the Quality Management Systems and monitors the performance and health of those Quality Management Systems through metrics and analytics.
• Assesses related product quality issues and escalate to upper management as appropriate.
• Assures the highest levels of internal customer satisfaction around the world, responding to internal customer feedback, supporting internal customer needs and help to ensure reliable, safe and effective, high-quality, end-to-end product supply and outstanding regulatory compliance performance.
• Promotes a culture of compliance to regulations, standards, and procedures and risk management throughout the organization.
• Supports departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
• Ensures talent development processes are implemented and executed to maintain a healthy pipeline of quality & regulatory compliance talent for J&J Surgical Vision and overall JJ Vision and as part of the larger J&J Quality & Regulatory Compliance talent process.

Requirements

• Bachelor’s Degree
• Scientific Discipline, Engineering or equivalent related experience.

• 10 years of working experience in strategy and QMS execution in a highly regulated medical device global business.

• These >10 years must also include a minimum of 5 years experience in at least one of the following: manufacturing/quality operations, quality engineering, manufacturing engineering and/or R&D/New Product Development environment.
• Experience to include a minimum of 7 years management experience.
• Proven track record of results and strong leadership capabilities.
• Strong knowledge of process and product improvement methodologies (six sigma black belt certification highly desirable but not required).
• Knowledge, understanding and application of quality and regulatory compliance principles, concepts and practices related to quality systems regulated by domestic and foreign governments.
• Understanding and working knowledge of a broad set of regulations and standards such as, but not limited to, FDA Quality system Regulation 21 CFR Parts 820; ISO 13485, FDA Combo Regulation 21 CFR Parts 4; Current Good Manufacturing Practice (CGMP) regulation 21 CFR 210/211, and international regulatory requirements (Japanese MHLW, Brazilian ANVISA).
• Strong communication, organizational, collaboration and interpersonal skills.
• Strong business acumen required.

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year