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:

Boston, Massachusetts, United States of America, Jacksonville, Florida, United States of America, Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

Johnson & Johnson is currently seeking a Design Quality Director to join our Orthopaedics team located in Palm Beach Gardens, FL; Jacksonville, FL; Boston, MA; Raynham, MA; Warsaw, IN; West Chester, PA.

About Orthopaedics

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 passionate 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.jnj.com/medtech

Remote work options may be considered on a case-by-case basis and if approved by the Company.

We are searching for the best talent for Design Quality Director Velys Enabling Tech.

This position leads Franchise Quality for Robotics and Power Tools in the Velys Enabling Tech Platform. We are a fast-growing business unit committed to keeping people moving!

Work with us to enable a team of Engineers and Managers achieve compliant and commercially successful new product launches for a variety of equipment and digital platforms, helping standard of health! This includes but is not limited to products such as Velys Robotics Assisted Surgery, Velys Spine, Velys Power, Purevue. As a direct partner to the R& D organization, all product launches, lifecycle management and associated product Quality and compliance are under the position accountability.

Through great leadership the candidate is empowered to develop team talent, work assignments and the structure of a multi-site team with members located in different countries. You will also collaborate with a composite of functional partners including R& D, Supply Chain, Regulatory, and the commercial organization, to achieve common business results.

You will be the Quality authority for business development projects (Due Diligence or Divestitures/network optimization) that are regularly conducted.

You will also participate in audits explaining our execution of the Quality systems and be the PRRC for one legal manufacturer. You will be enabling policy and procedure changes and conduct continuous improvements for the purpose of serving our Customers as well as improving our effectiveness.

As a business leader, be an active member in several leadership teams and shape progress and decisions in R& D project choices, Quality systems optimization, usability. Be a sound business partner.

Ensure Quality remains Customer centric by enabling team to connect with different customers. Drive Customer experience improvements through product quality or other Quality related projects.

There is a strategic component to this role as well: you will work with different Robotics leaders across MedTech to shape the Quality and new product Development policies, ensuring product safety, efficacy, and performance.

You will be responsible for:

• Franchise Management Representative – Velys Enabling Tech, irrespective of other responsibilities, has the responsibility and authority that includes:
  • Ensuring that processes needed for the quality management system are documented.
  • Reporting to top management on the effectiveness of the quality management system and any need for improvement.
  • Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
• Ensures Effective Design Controls and effective implementation and utilization of quality tools for NPD activities.
• Monitors quality metrics across the business unit and execute corrective and preventive action as needed.
• Partners with business functions to provide governance and technical support for Base Business Life Cycle Management projects associated with Customer experience, safety, compliance, business continuity and cost improvements.
• Proactively evaluate, communicate, manage, and mitigate risk.
• Partner with R& D, Operations, Regulatory, and Marketing to assure all sustaining engineering and NPD quality deliverables are met in accordance with all regulatory standards, and risk management execution.
• Manage the Design Quality engineering resources across sustaining engineering and NPD projects.
• Know and follow all laws, standards, and policies that apply to one' s job, and maintain the highest levels of professionalism, ethics, and compliance at all times.
• Diligently participate in compliance program-related activities as denoted by Quality leadership.
• Provide leadership in all areas of the Quality System, including, but not limited to, corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.
• Provide leadership in the understanding of medical device regulations to other disciplines.
• Communicate effectively at all levels, both within Quality and cross functionally.
• Responsible for communicating business related issues or opportunities to next management level.
• Performs other duties assigned as needed.
  

Qualifications / Requirements:

• A minimum of BA or BS in a scientific field required. An advanced degree is preferred.
• A minimum of 10 years’ Quality Engineering management experience, including strategic and tactical planning or similar experience.
• Preferred experience in Medical Robotics or Digital Platforms
• A minimum of 5 years’ experience in managing FDA and ISO Medical Device Quality and facility inspections.
• Proven record of relating Customer need and Product Quality and translate unmet needs into tangible decision making and implemented changes in a platform.

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, please email the Employee Health Support Center (ra-employeehealthsup@ its.jnj.com) or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

The anticipated base pay range for this position is:

$160, 000-$276, 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 Co-Ops and Intern Positions: 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) Positions Represented by CBA: This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement. 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.