Senior Director, Quality TECA

ppAt Johnson Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 /p pAs 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. /p h3Job Function: /h3 pQuality /p h3Job Sub Function: /h3 pRD/Scientific Quality /p h3Job Category: /h3 pPeople Leader /p h3All Job Posting Locations: /h3 pWest Chester, Pennsylvania, United States of America, Zuchwil, Switzerland /p h3Job Description: /h3 pJohnson 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. /p h3About DePuy Synthes /h3 pDePuy 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. /p h3Job Summary /h3 pSenior 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. /p ul liActs as the Quality Management Representative for Synthes West Chester, PA sites: Headquarters, Technology Center, and Wilson Drive Development Center. /li /ul h3Duties Responsibilities /h3 pUnder limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson Johnson, procedures and guidelines, this position: /p ul liWill be a member of DS TECA Platform Operating Committee and will provide the quality strategic vision for the organization. /li liWill provide guidance and coaching to all levels within the Quality organization and Quality leadership for the business. /li liWill partner with RD, Supply Chain, Regulatory Marketing to assure all LCM/NPI engineering and quality deliverables are met within quality, cost, and schedule targets. /li liWill 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. /li liWill manage overall quality budget, ensuring effective allocation of resources and investments to achieve quality objectives. /li liWill be accountable for quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed. /li liWill be responsible for the Synthes Quality Management Review. /li liWill support Quality related activities for product issue escalation, investigations (PIE/PIA) and QRB. /li liWill partner with Supplier Quality and Manufacturing, to ensure Quality strategy is aligned with JJ Med Tech Quality strategies. /li liWill host FDA/TUV/BSI and other Health Authority audits. /li liResponsible for communicating business related issues or opportunities to next management level. /li liResponsible 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 /li liResponsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. /li liPerforms other duties assigned as needed. /li /ul h3Experience Education /h3 ul liA minimum of a bachelors degree in a technical field is required. /li liA minimum of 12 years quality assurance management experience in medical devices is required. /li liStrong knowledge of design control requirements is required. /li liDirect experience leading Notified Body/FDA audits is required.

Strong knowledge of FDA and EU regulatory compliance for Medical Devices is required. /li liPrevious experience managing multiple projects is a required. /li liExperience of developing concise and audience-focused communications, both written and for presentations is required. /li /ul h3Required Knowledge, Skills, Abilities, Certifications/Licenses Affiliations /h3 ul liStrong problem solver with a proven ability to identify multiple possible solutions when faced with quality issues/opportunities. /li liAbility to effectively present complex information in a clear and concise manner is required. /li liStrong relationship builder who can earn the trust of internal and external stakeholders such that quality is positioned to contribute in a strategic, proactive way. /li liAbility to effectively negotiate and influence upper management, other departments and regulatory agencies is required. /li liHighly motivated individual with excellent interpersonal communication skills, and strong facilitation and executive coaching skills. /li liAbility to clearly communicate to a variety of audiences, both big picture ideas as well as technical details is required. /li liExperience of developing concise and audience-focused communications, both written and for presentations is required. /li liExcellent communication and interpersonal skills are required. /li /ul pJohnson 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 under 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. /p pJohnson 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. /p p#DePuySynthesCareers /p h3The anticipated base pay range for this position is : /h3 pAdditional Description for Pay Transparency: /p pSubject 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)). /p pThis position is eligible to participate in the Company’s long-term incentive program. /p pSubject to the terms of their respective policies and date of hire, employees are eligible for the following time off

benefits

• /p ul liVacation –120 hours per calendar year /li liSick 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 /li liHoliday pay, including
• Floating Holidays –13 days per calendar year /li liWork, Personal and
• Family Time - up to 40 hours per calendar year /li liParental
• Leave – 480 hours within one year of the birth/adoption/foster care of a child /li liBereavement
• Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year /li liCaregiver Leave – 80 hours in a 52-week rolling period10 days /li liVolunteer Leave – 32 hours per calendar year /li liMilitary
• Spouse Time-Off – 80 hours per calendar year /li liAdditional information can be found through the link below. /li /ul pCo-Ops and
• Intern Positions
• Please use the following language: /p pCo-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. /p pCo-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. /p pCo-Ops and
• Interns are eligible to participate in the Company’s consolidated retirement plan (pension). /p pFor additional general information on
• Company benefits, please go to: /p /p