We are searching for the best talent for senior quality engineer (temporal 12 meses) to be in juarez chih., mx salvarcar plant
you will be responsible for :
under general direction and in accordance with all applicable federal, state, and local laws/regulations and corporate johnson & johnson, procedures and guidelines, this position:
* 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 number of 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 result in the development of new or refined equipment, materials, processes, products, and/or methods.
* assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary, data are insufficient or confirmation by testing is advisable.
* 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:
* bachelor’s degree in a related field, along with a minimum of 4 – 6 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. Master’s degree is preferred.
* american society for quality (asq) certification, six sigma experience, and/or knowledge of process excellence tools is desirable.
* knowledge of gd&t (geometric dimensioning and tolerancing) is desirable.
* ability to develop and implement quality standards.
* thorough knowledge of quality and operations systems and processes, including gmp and qsr requirements for medical devices.
* thorough knowledge of leading-edge quality engineering, design control, and verification and validation (v&v) tools and methodologies.
* ability to apply project management skills to ensure fulfillment of new product development requirements.
* demonstrated auditing and problem-solving skills.
* understanding of six sigma and business excellence tools and methodologies. Lean manufacturing experience desirable.
* ability to train and mentor a diverse array of employees on quality topics.
* good understanding of theoretical and practical fundamentals and experimental engineering techniques.