Quality Engineer Ii

**"Johnson & Johnson companies are equal opportunity employers"**- At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity._- Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world._- When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough._**COMPANY****QUALITY ENGINEER II - (SEGUNDO TURNO)****JOB SUMMARY**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.**DUTIES AND RESPONSIBILITIES**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 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.- Write 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).- Help to 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 support in quality improvement opportunities as appropriate to legacy products, continuous improvement and customer satisfaction.- Assist in planning necessary to ensure effective product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans.- Support vendor audits as technical lead as needed and support Supplier Quality as Franchise Quality representative as appropriate.- Support NC, CAPA, Internal Audit, Training and QS activities as needed and ensures compliance to all applicable due dates.- 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.- Moderate exercise of judgment is required on details of work and in making selections and adaptations of engineering alternatives.- Supervisor or Sr./Staff/PMgr screens assignments for unusual or difficult problems and reviews techniques and procedures to be applied on non-routine work.- Receives general direction on new aspects of assignments.- Performs work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features for which there are precedents.- Responsible for communicating business related issues or opportunities to next management level.- Responsible for 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.- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.- Performs other duties assigned as needed.**Calificaciones**EXPERIENCE AND EDUCATION**- 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. Masters degree is preferred.**REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES AND AFFILIATIONS**- American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.- Familiarity of G