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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:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Palm Beach Gardens, Florida, United States of America

Job Description:

We are searching for the best talent for Supply Chain Quality Director, Velys Enabling Tech. Work should be onsite in our state-of-the-art Palm Beach Gardens, FL Capital Equipment campus. Considerations for Hybrid from this site can be given for the right candidate.

About Depuy Synthes

Fueled by innovation at the intersection of biology and technology, we are developing the next generation of smarter, less invasive, more personalized treatments.

Are you enthusiastic about improving and expanding the possibilities of Orthopaedics? Ready to join a team that is reimagining how we heal? Our Orthopaedics teams help keep more than six million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnjmedtech.com/en-US/companies/depuy-synthe (https://www.jnjmedtech.com/en-US/companies/depuy-synthes) s

Lead Supply Chain Quality across several sites for our suite of Robotic Equipment, Power Tools and Digital Solutions.

+ Establish and maintains Quality System procedures and controls ensuring that quality of the product conforms to established company and applicable regulatory standards.

+ Ensures the Quality system is in accordance with requirements of FDA 21 CFR Part 820, ISO13485, EU MD Directive/Regulations, Japan JPAL, Canada CMDCAS, Brazil ANVISA, Australia TGA and other applicable regulatory standards.

+ Ensures the manufacturing plants and distribution centers assess the Quality System effectively through Management Review/Internal Audits and implements corrective/preventive, and improvement actions as appropriate. Drive outcome more through collaboration than unilateral enforcement.

+ Ensures the Supply Chain has resources with the appropriate competencies to execute the Quality System.

+ Establishes and monitors metrics for the measurement of Quality Indicators and Financials. Ensures the timely escalations of quality topics per applicable procedure. Has accountability to the metrics.

+ Responsible for the disposition of products or materials that do not meet standards and specifications.

+ Oversees the inspections prior to the processing of raw materials/components, the monitoring of environmental conditions, the validation of all manufacturing and clean/control rooms processes prior to sterilization (as applicable).

+ Initiates action to correct or prevent nonconformities and direct or control further processing and delivery of nonconforming products.

Ensure Flawless Design transfer and commercialization of New Products Development (NPD)

+ Provide the voice of Supply chain to evolute of the NPD Launch procedures, both in the QMS and also business processes.

+ Partner with R&D, Operations, Regulatory & Marketing to assure all NPD Quality deliverables are met within cost, quality, and schedule targets.

+ Manages the Supply Chain Quality Engineering resources and allocates across NPD projects as needed to support business objectives.

Be a transformative leader for a fast growing platform.

+ Regularly update the Quality strategy and develop transformative projects enabling the continuation of fast-growth in the Supply Chain platform.

+ Informing Regulatory Affairs as appropriate of substantial changes to Quality Systems.

+ Responsible for the recruitment, supervision, training, and development of Quality personnel.

+ Develops and disseminates strategy for talent attraction, development, and retention to enhance the Quality talent pipeline.

+ Leads FDA/BSI and other foreign regulatory audits.

+ Member of the Franchise Leadership team.

+ Is the Quality Management Representative for the Palm Beach Garden site and Power Tool Franchise.

+ Communicate business related issues or opportunities to next management level.

+ For those who supervise or manage a staff, 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

+ Ensure personnel and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

+ Performs other duties assigned as needed.

+ Acts as Person of Responsible for Regulatory Compliance (PRRC) for the Legal Manufacturer*

Qualifications / Requirements:

+ A minimum of a bachelor’s degree is required, preferably in Engineering or Science discipline.

+ A minimum of 10 years of experience in a GMP or ISO regulated industry is required, Medical Device is preferred.

+ A minimum of 5 years of direct people management experience is required.

+ 3 year experience in Capital equipment, medical robotics, power tools or digital solutions preferred.

+ NPD Quality Experience preferred specific to QSR Design Control requirements.

+ Strong knowledge of FDA and EU regulatory compliance for Medical Devices is required.

+ Experience leading Notified Body/FDA audits.

+ Strong skills with a proven track record in managing validation and Risk Management is required.

+ Experience in Project Management, Cost Accounting Principles; Operations Processes, Systems Development and Integration are required.

+ Excellent communication and interpersonal skills are required.

+ Ability to effectively present complex information in a clear and concise manner is required.

+ Process Excellence and Lean experience desired.

+ Ability to effectively negotiate and influence upper management, other departments and regulatory agencies are required.

+ Ability to clearly communicate to a variety of audiences, both big picture ideas as well as

+ Technical details are required.

+ Analytical and critical thinking skills are essential.

+ Strong diligence.

+ Excellent organizational and time management skills.

+ Must be able to work under pressure due to reporting deadlines.

+ Must be able to work independently and prioritize with little supervision.

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.

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.

\#LI-Hybrid

\#LI-Onsite

Required Skills:

Preferred Skills:

Business Alignment, Collaborating, Compliance Management, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Mentorship, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Planning, Tactical Thinking, Technical Credibility

The anticipated base pay range for this position is :

$146,000-$251,850

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. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.