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at johnson & johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in innovative medicine and medtech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
job function
* quality
job sub function
* quality assurance
job category
* professional
all job posting locations
* ciudad juárez, 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. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
about cardiovascular
fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of cardiovascular? Ready to join a team that’s reimagining how we heal? Our cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (afib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
quality engineer ii
location: cd. Juarez, plant salvarcar
purpose
under general supervision, participate in new and sustaining 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. Supports quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Will receive technical guidance on complex problems, but independently develops approaches and solutions. Work is usually well defined and is checked for progress and reviewed for accuracy upon completion.
you will be responsible for
* assisting in a supporting role on new product development, sustaining and supply chain quality projects. Assist in the development of effective quality control and associated risk management plans.
* writing process and product validation protocols and reports, equipment qualifications, engineering change orders.
* using statistical tools to analyze data, make acceptance decisions, and improve process capability (six sigma, spc, doe).
* 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 support in quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.
* assisting in planning necessary to ensure effective product acceptance (inspection instructions, equipment and gauge requirements, sampling plans).
* supporting vendor audits as technical lead and supporting supplier quality as franchise quality representative as appropriate.
* supporting nc, capa, internal audit, training and qs activities as needed and ensuring compliance to all applicable due dates.
* initiating and investigating corrective and preventive 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.
* applying moderate exercise of judgment on details of work and in making selections and adaptations of engineering alternatives.
* performing work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features for which there are precedents.
* communicating business related issues or opportunities to next management level.
* ensuring subordinates, if applicable, 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.
* ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
* performing other duties assigned as needed.
qualifications / requirements
* bachelor’s degree in a related field, along with minimum 2–4 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.
* familiarity with gd&t concepts is desirable.
* ability to develop and implement quality standards.
* some knowledge of or education in quality and operations systems and processes, including gmp and qsr requirements for medical devices.
* some knowledge of or education in quality engineering, design control, and verification and validation (v&v) tools and methodologies.
* ability to apply project management skills to fulfill new product development requirements.
* problem solving skills.
* verbal and written communication skills and ability to effectively communicate with internal and external personnel.
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