At Johnson & Johnson,u202fwe believe health is everything. Our strength in healthcare innovation empowers us to build au202fworld where complex diseases are prevented, treated, and cured,u202fwhere treatments are smarter and less invasive, andu202fsolutions are personal.u202fThrough 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.u202fLearn more at https://www.jnj.com Job Function: Supply Chain Engineering Job Sub Function: Quality Engineering Job Category: Scientific/Technology All Job Posting Locations: Aachen, North Rhine-Westphalia, Germany Job Description: 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/ Johnson & Johnson is currently seeking an Sr. Supplier Quality Engineer to join our Abiomed Team. The Supplier Quality Engineer is responsible for cross-functional Quality Assurance, Quality Management and Quality Compliance associated with all supplier related Abiomed products and processes. Tasks: Ensure compliance of supplier management to all applicable quality system regulations. Ensure stable and improving quality of supplied direct materials, services and finished goods. Work with supplier engineering, design engineering, other engineering functions as well as procurement and quality inspection to ensure necessary processes are in place, verified and controlled. Represent QA on Supplier Part Qualifications (SPQs), Supplier Audit follow ups, Supplier selection and qualification, Engineering Change Orders (CRs), Material Review Board (MRB), Supplier Corrective Action Requests (SCARs), Corrective and Preventive actions (CAPA) and Deviations. Aggregate relevant data and report on quality system metrics: material nonconformity, supplier performance, supplier corrective actions, supplier related CAPAs Work closely with the suppliers on quality improvements. This can include visits to the supplier site. Support internal- and external auditing requirements (system compliance) Assure compliant processing of identified supplier related non-conformities including bounding, root cause investigations, Dispositions and associated corrective / preventive actions Continuously improve supplier quality related processes, support establishing supplier Process FMEA and cross-functional risk evaluation for supplier related failure modes Closely collaborate with other global Abiomed sites. Requirements of Job Owner: Educational Skills: University degree in Engineering discipline or comparable Work Experience: Experience with formal problem-solving methodologies and deductive skills Special Requirements: Good understanding of basic MedTech regulatory requirements such as FDA QSR and ISO13485, ISO 14971 is an advantage. Experience with handling of non-conforming material including root cause investigations. Experienced in qualifying supplier parts, equipment, and processes; statistical data analysis, MS Office and SAP usage