Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity. At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale and experience to reimagine the way healthcare is delivered and help people live longer, healthier lives. In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, vision and interventional solutions with the big ideas of others to design and deliver physician and patient-centric products and solutions. As pioneers in medical devices, we continually focus on elevating the standard of care\xe2\x80\x94working to expand patient access, improve outcomes, reduce health system costs and drive value. We create smart, people-centered healthcare to help the patients we serve recover faster and live longer and more vibrantly. JOB SUMMARY Job purpose of Quality System Lead is to plan, coordinate and direct Quality Systems designed to ensures continuous compliance and consistent with established standards by performing the following duties and responsibilities. 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:

• Responsible for managing overall site Quality Systems Program in compliance with all applicable regulations and policies, including FDA, safety and environmental.

• Lead QMS process and activities as part of Quality Systems.

• Has Knowledge and experience of Change Control, Validation, PQR, QSMR & PQR / APQR

• Train other staff on QMS elements.

• Provide inputs to QMS reports, requirement and other information in response to requests for proposals, quotes and other business opportunities.

• Utilize problem solving skills and statistical techniques to support QMS that are aligned with the overall quality and business vision.

Compliance & Training

• Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and notify any violation or deviation to the immediate supervisor or appropriate authority.

• Complies with all training requirements to perform duties of the job.

• Ensure adherence/compliance to Records Management policies and procedures, as applicable.

Qualifications

EXPERIENCE AND EDUCATION

• Graduate in Pharmaceutical Sciences / Postgraduate in Science / Bachelors in Engg. with minimum 8 -12 years relevant experience in Quality Assurance / Quality Operations/Quality System function in Pharmaceutical/ Medical Device industry.

• Experience of working in a regulated industry like Pharmaceutical / Medical Devices is highly desirable.

• Working knowledge of Laboratory Software\xe2\x80\x99s is preferred. For example, LIMS system, ETQ NC, ETQ CAPA, Trackwise, etc.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS Technical & Behavioral Skills

• Demonstrate knowledge and application of MDR 2017, Drugs & Cosmetics Act, ISO-9001, ISO-13485 and other relevant international standards for medical devices.

• Ability to technically review documents from other areas for departmental impact.

• Strong technical, planning and execution capabilities.

• Ability to analyze, balance and prioritize risk.

• Acquaintance with Good Manufacturing Practices, Machines and Equipment(s).

• Operational excellence in Quality and Compliance activities.

• Very good presentation & Report Writing skills

Are you ready to impact the world? Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.