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:
* 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 quality improvement opportunities for legacy products, continuous improvement, and customer satisfaction.
* developing and establishing effective quality control and support associated risk management plans.
* writing, reviewing and/or approving process and product validation protocols and reports, equipment qualifications, and engineering change orders.
* using statistical tools to analyze data, make acceptance decisions, and improve process capability (six sigma, spc, doe).
* determining sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products.
* ensuring 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.
* providing all planning necessary to ensure effective product acceptance, including part qualifications, specification development, and sampling plans.
* supporting vendor audits as technical lead and supplier quality as quality representative as appropriate.
* initiating and investigating corrective and preventative actions (capa) as appropriate.
* assisting in complaint analysis as appropriate.
* assisting regulatory affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.
* participating in design reviews and pre-validation assessments to ensure safe and environmentally sound start-up of new processes.
* making decisions independently on engineering problems and methods and representing the organization in conferences to resolve important questions and to plan and coordinate work.
* consulting with supervisor and providing guidance as needed concerning unusual problems and developments.
* supervising and/or providing guidance to inspectors and technicians in quality lcm, quality operation or quality assurance activities.
* in a supervisory capacity, planning, developing, coordinating, and directing a medium-sized engineering project or a number of small projects with varying levels of complexity.
* as an individual researcher, carrying out assignments requiring the development of new or improved techniques or procedures.
* assessing the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary.
* communicating business-related issues or opportunities to the next management level.
* ensuring subordinates follow all company guidelines related to health, safety and environmental practices.
* ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
* performing 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.
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