Staff Source Quality Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About MedTech

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

Your unique talents will help patients on their journey to wellness. Learn more at Cardiovascular

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

Are you passionate about improving and expanding the possibilities of Cardiovascular Ready to join a team thats reimagining how we heal Our Cardiovascular team develops leading solutions for heart recovery electrophysiology and stroke. You will join a proud heritage of continually elevating standards of care for stroke heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at Electrophysiology

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

As Johnson & Johnson MedTech Electrophysiology we have one goal to ensure those with atrial fibrillation can live the lives they want. For more than 30 years weve been the global market leader in the science and technology of cardiac arrythmia treatment. Our suite of tools means electrophysiologists are empowered to personalize their approaches for patients with effective and reproducible workflows. Together were changing what it means to be diagnosed with atrial fibrillation or other cardiac arrhythmias.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for STAFF SOURCE QUALITY ENGINEER (Temporary 12 months)

Purpose: Participates supports and leads activities related to the suppliers of raw material components finished product and services for the receipt inspection of the materials such as the implementation of corrective and preventive actions rating validation and certification as well as to perform quality improvement projects. If CSS Position: This position will have responsibilities across ETHICON and Cardiovascular and Specialty Solution (CSS) Companies Johnson and Johnson Family of Companies) including a span of multiple product platforms such as General Surgical Devices Sutures ENT Infection Prevention Electrophysiology and Surgical and Non-Surgical Aesthetics.

You will be responsible for:

Under limited supervision and in accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

• Provides support to the different business units of the plant when it comes to monitoring situations regarding supplier quality.

• Provides support to the receipt inspection group (technician group leader supervisor etc.) in the decision taking and the monitoring of non-conforming material of the supplier.

• Responsible for the monitoring of the investigations with suppliers related with non-conformant materials.

• Responsible of generating corrective and preventive actions to the supplier and to verify the implementation and effectiveness of the actions obtain their approval and their closing.

• Deals directly with suppliers and external manufacturers to ensure that the produces and/or services received meet the requirements and specifications.

• Writes and generates new quality standards or updates the existing ones depending on what is required.

• Develops and implements continuous improvement programs with suppliers.

• Participate and attends to meetings of quality metrics and others in which he/she is required.

• Responsible of answering implementing and closing corrective and/or preventive actions internally as well as externally.

• Collects data to generate reports and distributes them to publish the performance of the suppliers.

• Provides support to the supplier in research and continuous improvement techniques (SPC Gage R&R etc).

• Leads and supports supplier development initiatives to obtain their certification and eliminate or reduce receipt inspections

• Participates in activities of rating validation and certification of suppliers inspection methods and equipment.

• Participates in the analysis and monitoring of client complaints related to raw materials components suppliers finished goods or services.

• Participates in the risk assessment and escalation of situations related to raw materials components supplier finished goods and services when necessary.

• Complies with the companys regulations local state and federal as well as with the security health and environmental procedures.

• Participates in Kaizen PE (GB/BB) and Lean projects.

• Interacts with other groups of the organization in the development and selection of suppliers.

• Provides support to the different business units of the plant in regards of monitoring supplier quality situations.

• Provides support to the suppliers quality auditing group by providing performance information or in the risk assessment when necessary.

• Visits and evaluates suppliers through the execution of audits or suppliers technical evaluations if required.

• Participates in the introduction of new produces in regard to new components and suppliers.

• Responsible of generating and updating the quality agreements with suppliers.

• Leads and participates in changes required by the suppliers (material process methods systems transfers etc.) jointly with other areas of the organization.

• Participate in the research presentation and risk assessment of non-conformant components of the suppliers.

• Responsible of communicating situations related to the business or opportunities to the next management level.

• Responsible of completing the trainings assigned by the quality system of the organization.

• Responsible of approving and/or escalating exceptions of suppliers in the specifications.

• Responsible of generating revising and approving changes in the procedures work instructions specifications inspection reports the changes system of the organization related to suppliers or with the quality management process of suppliers.

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for ensuring 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

• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures

• Performs other duties assigned as needed.

Qualifications / Requirements:

• Professional engineering or bachelors degree. 5 to 7 years of experience in other positions with similar functions and responsibilities.

• More than (5) five years of experience in quality area supplier quality area or practicing as a professional in an industrial environment

• Knowledge in corrective and preventive actions systems.

• Knowledge of statistical analysis and problem solving techniques.

• Basic knowledge of project management tools.

• Thorough knowledge of GMP QSR ISO 13485 (Preferably).

• Experience in development validation and certification of suppliers.

• Management of drawings and specifications as well as departmental procedures.

• Knowledge of the document control system preferably JDE and cPDM.

• Use of computer and statistics programs as well as six sigma and lean manufacturing.

• Ability for organized self-directed work that requires minimum supervision.

• Ability to negotiate and influence on others being mentor to other engineers with less experience.

• Ability to take sensible decisions and of high adherence to the CREED (preferably).

• Ability to develop and implement Quality standards.

• Understanding of financial and business principles.

• Availability for first or second shift and overtime.

• Availability to travel when required.

• English language 85% demonstrated proficiency in spoken and written English.

• Desirable certification as Green belt or higher rank.

• Desirable certification as CQA or CQE (by ASQ).

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