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At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to 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, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.
We are in this for life.
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We are searching for the best talent for Senior Quality Engineer to be in Ciudad Juarez, Mexico.
Purpose:
Participate in new product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, quality processes to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices. Drive quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Shares technical expertise with others and helps develop junior level engineers.
You will be responsible for:
Primary responsibilities include working in Quality Engineering and with other functional groups in support of new product/process development, quality operations or quality assurance.
Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.
Develop and establish effective quality control and support associated risk management plans.
Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products.
Ensure that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDR, and product is properly transferred to manufacturing.
Provide all planning necessary to ensure effective product acceptance. This includes, but is not limited to, part qualifications, specification development, and sampling plans.
Support vendor audits as technical lead as needed and support Supplier Quality as Quality representative as appropriate.
Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
Assist in complaint analysis as appropriate.
Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.
Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
Consults with supervisor and provide guidance as needed concerning unusual problems and developments.
Responsible for one or more of the following as needed:
Supervise and/or provide guidance to Inspectors and Technicians in Quality LCM, Quality Operation or Quality Assurance activities.
In a supervisory capacity, plans, develops, coordinates, and directs a medium-sized engineering project or a few small projects with varying levels of complexity.
As an individual researcher, carries out assignments requiring the development of new or improved techniques or procedures.
Work is expected to result in the development of new or improved techniques or procedures.
Work is expected to r
