*job function*:
quality
*job sub function*:
quality assurance
*job category*:
professional
*all job posting locations*:
ciudad juarez, chihuahua, mexico
*about medtech*
fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
*we are searching for the best talent for staff quality engineer to be in juarez, chih. Independencia plant*
*purpose*:
the quality engineer staff plans or adapts the new methods or procedures to control or coordinate all the aspects of several project at the same time and in the solution of the related and technical projects. The engineer staff is an emergent authority in a specific technical field, exercising a considerable freedom in the determination of the technical objectives of the assignments. In general, it is expected that his/her work result in the development of new or improved methods to reduce risks, equipment, materials, processes, products and technical methods. The engineer staff acts as a mentor for lower hierarchy personnel and provides advice to upper management about technical matters. The quality engineer staff will use tools and quality engineering practices for the effective and efficient development of transfers and maintenance of products / processes in the whole life cycle of the product. The holder of the position will also use the quality engineering principles and investigation skills for the resolution of complex problems (technically) associated to the manufacturing process at a local or franchise level, including those related to escalations. He/she will use the appropriate risk management to prevent the unforeseen failure modes and improve the capacity of the processes. This person will provide support to the business process and supervisor or direct technicians.
*you will be responsible for*:
in accordance with all applicable federal, state and local laws/regulations and corporate johnson & johnson, procedures and guidelines, this position:
- monitor all fgqa quality assurance functions.
- establish and maintain appropriate documentation as required for quality assurance activities and the quality documentation systems.
- develop statistical sampling plans and perform process capability studies.
- implement process control systems and provide technical support for process validations.
- provide qs support in product transfers and new products development.
- assist in training new engineers, train technicians and supervisors in process changes.
- perform complaint analysis investigation as needed.
- participate in process/ quality improvement projects.
- support cogs initiatives.
- responsible for following and administering safety.
- compliance with safety policies and procedures.
- assist, review & approve non-conformances investigations & non-conforming product dispositions.
- other responsibilities may be assigned and not all responsibilities listed may be assigned.
- responsible for communicating business related issues or opportunities to next management level
*qualifications / requirements*:
- as minimum, bachelor, preferably in engineering: mechanical, electrical, industrial or applicable science.
- 6 to 8 years of work experience or demonstrated performance.
- use of computer packages.
- ability to communicate in english, orally and written.
- knowledge of product / process risk management (fda and iso regulations), preferably.
- advanced technical training and experience in the use of statistics and lean methodologies and
- six sigma, including measuring system analysis, spc, does, reliability, etc.
- strong knowledge of statistical software packages, preferably, with the capacity of previsualizing,
- create graphs and analyze data and be capable of presenting data that facilitates the taking of decisions.
- ability to perform an “active involvement” in the solution of problems and resolution of problems, preferably.
- capacity to solve problems and provide good judgment, highly desirable. Demonstrated management abilities of projects and leadership projects, preferably.
- certifications such as cqa and cqe (preferably), cba and green belt are a plus.
*required skills*:
*preferred skills*:
business alignment, business savvy, coaching, communication, compliance management, continuous improvement, fact-based decision making, human-centered design, iso 9001, issue escalation, problem solving, quality control (qc), quality management systems (qms), quality standards, regulatory environment, standard operating procedure (sop)