Senior Director, Quality TECA

Job Function: Quality Job Sub Function: RD/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, 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 RD, Supply Chain, Regulatory Marketing to assure all LCM/NPI engineering and quality deliverables are met within quality, cost, and schedule targets. Will partner with RD, 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 JJ 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 origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource. #DePuySynthesCareers Additional Description for Pay Transparency: 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 period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year Additional information can be found through the link below. Co-ops and Intern Positions: Please use the following language: Co-ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year. Co-ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension). For additional general information on Company benefits, please go to: - Website #J-18808-Ljbffr