The Staff Supplier Quality Engineer is responsible to lead, and drive activities related to the suppliers of raw material, components, finished goods 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. 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 product (including reprocessed products).
DUTIES & RESPONSIBILITIES
Under general direction 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 departments when it comes to monitoring situations regarding supplier quality.
- Provides support to the inspection group (technician, group leader, supervisor, etc.) in the decision making 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 risk assessment and escalation of situations related to raw materials, components, supplier finished goods and services when necessary.
- Complies with the company’s 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 supplier’s 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 products 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, etc. in the changes system of the organization related to suppliers or with the quality management process of suppliers.
- 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
EXPERIENCE AND EDUCATION
- Professional engineering or bachelor’s 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.
- 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.
- 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 make sensible decisions based on the J&J CREDO.
- Ability to develop and implement Quality standards.
- Understanding of financial and business principles.
- Availability to travel, when required.
- Desirable certification as Green belt or higher rank.
- Desirable certification as CQA or CQE (by ASQ).