Senior Director, Quality TECA

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: R&D/Scientific Quality Job Category: People Leader All Job Posting Locations: West Chester, Pennsylvania, United States of America, Zuchwil, Switzerland Job Description: Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. About DePuy Synthes DePuy Synthes is a global leader in Orthopaedics, advancing patient care through innovative solutions across joint reconstruction, trauma, spine, sports medicine, and related surgical technologies. As DePuy Synthes separates from Johnson & Johnson to become the world’s largest, most comprehensive Orthopaedics-focused company, the organization is entering a defining chapter—establishing its own corporate identity, voice, culture, and reputation while continuing to serve patients, customers, and healthcare systems around the world. Job Summary Senior Director, Quality TECA will be accountable for the development, execution, and delivery of quality strategies for DS TECA lifecycle management (LCM) and new product introduction (NPI) engineering activities. Acts as the Quality Management Representative for Synthes West Chester, PA sites: Headquarters, Technology Center, and Wilson Drive Development Center. Duties & Responsibilities Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Will be a member of DS TECA Platform Operating Committee and will provide the quality strategic vision for the organization. Will provide guidance and coaching to all levels within the Quality organization and Quality leadership for the business. Will partner with R&D, Supply Chain, Regulatory & Marketing to assure all LCM/NPI engineering and quality deliverables are met within quality, cost, and schedule targets. Will partner with R&D, Supply Chain, Regulatory & Marketing to assure there is appropriate execution of risk management, design controls and process validation for new and existing products. Will manage overall quality budget, ensuring effective allocation of resources and investments to achieve quality objectives. Will be accountable for quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed. Will be responsible for the Synthes Quality Management Review. Will support Quality related activities for product issue escalation, investigations (PIE/PIA) and QRB. Will partner with Supplier Quality and Manufacturing, to ensure Quality strategy is aligned with J&J Med Tech Quality strategies. Will host FDA/TUV/BSI and other Health Authority audits. Responsible for communicating business related issues or opportunities to next management level. 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. Experience & Education A minimum of a bachelors degree in a technical field is required. A minimum of 12 years quality assurance management experience in medical devices is required. Strong knowledge of design control requirements is required. Direct experience leading Notified Body/FDA audits is required. Strong knowledge of FDA and EU regulatory compliance for Medical Devices is required. Previous experience managing multiple projects is a required. Experience of developing concise and audience-focused communications, both written and for presentations is required. Required Knowledge, Skills, Abilities, Certifications/Licenses & Affiliations Strong problem solver with a proven ability to identify multiple possible solutions when faced with quality issues/opportunities. Ability to effectively present complex information in a clear and concise manner is required. Strong relationship builder who can earn the trust of internal and external stakeholders such that quality is positioned to contribute in a strategic, proactive way. Ability to effectively negotiate and influence upper management, other departments and regulatory agencies is required. Highly motivated individual with excellent interpersonal communication skills, and strong facilitation and executive coaching skills. Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details is required. Experience of developing concise and audience-focused communications, both written and for presentations is required. Excellent communication and interpersonal skills are 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 o