SECTION 1: 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. SECTION 2: DUTIES & RESPONSIBILITIES* Under general directionand 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. AVISO: Este es un documento controlado, confidencial, y con derechos reservados. Revisar si es la revision mas actualizada.WARNING: This is a controlled proprietary and confidential document.**Qualifications**:
