Senior Director, Quality & Vision Equipment

Job Function

Quality

Multi-Family Quality

People Leader

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

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.

• Full, direct supervisory responsibilities of Quality including quality and compliance for Supply Chain related activities in J&J Vision Surgical Equipment.
• Ensures the proactive identification of quality and compliance risks and the corresponding improvement plans.
• Strategic planning and execution as a member of J&J Vision Q&C leadership team.
• Directly accountable for business results within J&J Visiom Surgical Equipment.
• Establishes strategy for quality and compliance across the J&J Surgical Vision manufacturing sites and ensures adequate resources to support global programs. Effectively partners with senior management to support audit readiness/preparation for risk mitigation and corrective and preventative actions and on-going process improvements.
• Partners with Operations, R&D and Process Excellence to set strategies that drive continuous improvements for the customer. Champions continuous improvement initiatives across the segment that incorporates risk management, process excellence and measurement systems to align business benefits with action and resource prioritization.
• Ensures all products are manufactured to the highest safety and quality levels.
• Assures a risk management approach which achieves an acceptable risk-benefit balance to quality, compliance and business objectives. Through risk management strategies, supports the franchise in delivering business results and fosters a culture change within the segment that embraces risk management tools and techniques.
• To recruit and further develop high caliber Quality and Compliance professionals.

• 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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are…