Job Description - INGENIERO DE CALIDAD SENIOR (2406209785W)Position: INGENIERO DE CALIDAD SENIORLocation: Ciudad Juarez, MexicoDescription:At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, impacting the health of more than 1 billion patients and consumers every day for over 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions.Biosense Webster, Inc. is recognized worldwide as a leader in the science behind the diagnosis and treatment of cardiac arrhythmias.Purpose:Participate in new product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, and 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.Your Responsibilities:Work in Quality Engineering and with other functional groups in support of new product/process development, quality operations, or quality assurance.Utilize Quality Engineering tools/processes in development and implementation of practices for effective product lifecycle management.Lead quality improvement efforts for 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.Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).Ensure that development activities follow design control requirements and that the product is tested per applicable standards.Support vendor audits and initiate Corrective and Preventative Actions (CAPA).Assist in complaint analysis and work with Regulatory Affairs on submissions for process changes.Qualifications:Bachelor's degree in a related field 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. A Master's degree is preferred.Desirable qualifications include: ASQ certification, Six Sigma experience, knowledge of GD&T, and experience with Lean manufacturing.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status.#J-18808-Ljbffr
