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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

People Leader

All Job Posting Locations:

Raynham, Massachusetts, United States of America

Job Description:

About Orthopedics

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

Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 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

Johnson & Johnson is currently seeking a Quality Engineering Team Lead to join our team in Raynham, MA.

At Johnson & Johnson, we pride ourselves on our world-class products and our commitment to making a difference in the lives of people around the globe. As a Quality Engineering Team Lead, you will play a vital role in ensuring the quality of our products, maintaining our reputation as a leader in the industry. This is a unique opportunity to be part of a company that is dedicated to delivering innovative and life-changing healthcare solutions.

Are you a Quality Engineering Team Lead looking for a new and exciting challenge? Look no further and join our team!

Key Responsibilities:

• Supervises Quality Engineers and is accountable for conducting effective performance management.
• Responsible for managing operational aspects of their team (e.g., workflow, performance, and compliance), as well as ensuring achievement of team goals within expected standards.
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements), including providing support during internal and external audits.
• Conducts investigation, bounding, records documentation, review and approval of non-conformances, CAPAs and customer complaints. Raises quality issues as appropriate.
• Accountability for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
• Analyzes/reviews effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
• Represents as a Subject Matter Expert (SME).
• Supports or leads in developing validation strategies.
• Approves IQ, OQ, PQ, TMV or Software Validation.
• Partners with J&J Global Supply Chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management, and the investigation/correction of process failures when needed.
• Collects data and executes/conducts various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Documents, justifies, reviews or analyzes whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• Performs other duties assigned as needed.

Qualifications

Education:

• A Bachelor’s degree or equivalent in Engineering or related scientific field is required.

Experience and Skills:

Required:

• Minimum 4 years of relevant, professional work experience within the Medical Devices, Pharmaceutical and/or regulated industry.
• Strong knowledge of quality management systems and regulatory requirements (e.g., ISO 13485, FDA QSR).
• Exceptional problem-solving and analytical skills, with the ability to identify root causes and implement effective solutions.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Experience with CAPAs non-conformances, audits, and process validation.
• Strong trending and data analysis skills.
• Troubleshooting expertise.
• Proven competence to evaluate, communicate, and act upon significant risks, demonstrating leadership of the high standards of quality and compliance.
• Act with speed, flexibility, and accountability to achieve goals. Understands how own work impacts the enterprise and use understanding to make effective decisions and take actions and lead priorities effectively to deliver expected results.

Preferred:

• Process Excellence / Six Sigma Certification or equivalent preferred.

Other:

• This position will require to work onsite at Raynham, MA and may require up to 10% domestic or international travel.

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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

#LI-Onsite

The anticipated base pay range for this position is :

From $91,000 to $147,200

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be 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. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.