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 https: //www.jnj.com

Job Function:

Quality

Job Sub Function:

R& D/Scientific Quality

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

J& J MedTech Surgery, a global leader in surgery with products and solutions found in almost every operating room around the world, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues so that people may live longer, healthier lives.

Through our surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats, we deliver innovation to make a life-changing impact.

We are seeking a Senior Director, Quality and Compliance who shares our passion for ensuring the highest quality experiences for our patients and customers. This position supports the Wound Closure and Healing (WCH) platform, a market leader in surgical tissue healing with a broad portfolio including: Antibacterial sutures, Knotless Tissue Control Devices, Topical Skin Adhesives, Skin Closure Systems, and traditional absorbable and non-absorbable surgical sutures with innovative needle technologies.

The Senior Director, Wound Closure and Healing Quality & Compliance role is accountable for providing direct and indirect leadership to the Quality and Compliance (Q& C) functions that support the end-to-end product lifecycle in order to ensure a consistent and integrated Q& C approach across R& D, Supply Chain, and Commercial activities. This role ensures the development and execution of quality deliverables enabling effective and compliant innovation. In collaboration with Supply Chain and Commercial Quality organizations, this role ensures the success of the accountable business platform’s network strategies and a reliable supply of high-quality products. This leader works cooperatively with Johnson & Johnson leaders to implement programs to improve overall quality, improve operational efficiency, advance innovation, enhance organizational capability and diversity, and assure regulatory compliance.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Partners with R& D, Operations, Commercial, Supply Chain, and Quality Operations to assure quality and business deliverables and metrics are met. Identify systemic product and process improvement opportunities assuring appropriate investigation, correction, corrective and preventive action when needed.
• Provides vision and leadership in the identification, design, and implementation of World-Class Quality engineering systems to support the entire product life cycle with a focus on prevention and detection of defects at the earliest phase of product design, continuous improvement, and customer satisfaction.
• Ensures effective Technical Design Reviews and effective implementation and utilization of quality tools within R& D/New Product Development. Facilitate interaction and transfer of knowledge, as needed, between Product Development, Operations / Manufacturing, external manufacturers, and component / raw material suppliers.
• Responsible for building the capability of the organization and leading engineers to create effective Quality Engineering processes at all levels and throughout the organization. Develop and mentor Quality Engineers throughout the organization including matrix organizations to create and sustain a strong talent pipeline.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Required Education and Experience:

• A Bachelor’s Degree is required in engineering, science, or related technical field from an accredited school is required. A relevant advanced degree or equivalent experience is preferred.
• Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical)
• Experience leading multi-functional, multi-site, and/or international/global teams
• 12+ years in developing and implementing systems to ensure product/process quality
• Digital literacy, including Windows: word processing, project planning, presentation, e-mail, and spreadsheet software and advanced software pckages as necessary
• Minimum of 5 years supervisory experience

Preferred Knowledge, Skills, and Abilities:

• Knowledge of, and experience with, applicable standards and regulations in medical devices
• Proven experience with the application of Design Controls, Statistical Acumen, Quality Engineering, and risk management principles
• Proven track record of interaction with regulatory bodies
• Certification in Lean and Six Sigma methodologies
• Professional certifications relating to the quality profession (ex. ASQ)

LOCATION & TRAVEL REQUIREMENTS

• The location for this position is Raritan, NJ
• ≤ 25% of Time for Domestic/International travel

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The anticipated base pay range for this position is:

173, 000 - 299, 000

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits