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—working 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.
DUTIES & RESPONSIBILITIES*
• Leading, coordinating and executing the recurring validation activities according to validation master plan
• Leading of process characterization & development activities in projects and initiatives • Creating validation strategies, test plans, validation specifications, protocols and reports
Documenting changes of methods, processes and material in ADAPTIV (MVI)
• Leading the equipment qualification
• Planning, coordination, monitoring and evaluation of manufacturing equipment & process validation activities •
Training of employees in validation specifications, test plans, test methods, etc.
• Supporting the selection of processes / machines, taking into account the requirements of project and production as well as investment and cost aspects
• Ensuring an effective process risk management (FMEA) carrying out process risk analysis process participation in product risk analysis • Developing manufacturing processes under application / taking into account methodological concepts (Six Sigma, Lean).
• Supporting the root cause identification and implementation/documentation of corrective measures during the stabilization phase of a product / process development project
• Taking over of co-ordination and project management tasks for the Aurangabad site if no project manager is associated with the project
• Ensuring process optimization within the stabilization phase of assigned project • Engages to comply with ISO and FDA requirements
• Ensuring compliance to the Quality system requirements.
• Utilizing problem solving skills and statistical techniques to support product / processes controls that are aligned with the overall quality and business vision.
• Assuring that engineering department is appropriately run in a safe, clean and environmentally sound manner.
• Developing and analyzing statistical data and machine specification so as to determine present standards and establish proposed quality and reliability expectancy of finished product • Assisting in engineering budget preparation, goal tracking and in the business planning process. • Supporting for NCR’s investigation and performs trend analysis and report to Management
Participating in audits and gap assessments in support of the internal audit program and FDA readiness.
• Partnering with operations in the investigation / correction of process failure
• Developing safety culture in the engineering function
• Responsible for updating the Record retention schedule for Engineering department every year
• Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and notified 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 • Authorized for approval of Returnable Gate Pass, Invoices • Authorized for approval as per delegation process
• Responsible for communicating business related issues or opportunities to next management level.
• 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
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures • Performs other duties assigned as needed •
As IOSS area owners(if applicable) need to do following activities Overall responsibility to implement all expectations as communicated by chapter owners Ensure role and responsibility of individual to comply with EHSS expectation Ensure EHSS meeting, assessments, audits in the area. Ensure people attends EHSS TRAINING as per plan. Guide to area members to understand the EHSS expectations and track their Guide performance on implementation. Ensure monthly Gemba round in the area and 90% on time closer
EXPERIENCE AND EDUCATION*
Requires minimum 6 years of work experience with master degree in Engineering or minimum 10 years of work experience with bachelor degree in Engineering.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
• Knowledge of applicable and updated version of ISO 9001, ISO-13485, ISO-14001 requirements.
• Knowledge of local FDA, GMP, EHS & S and other statutory & regulatory standards applicable in manufacturing environment.
• Knowledge of continuous improvement tools, Lean Manufacturing & Six- Sigma. • Knowledge of SAP, Visio, MS Projects, Minitab, ADAPTIV, ETQ Audit, ETQ CAPA, ETQ NC & Compliance Wire
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.
This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.