Location: Spragueville, IA
Company: Abiomed
USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson Med Tech. Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees.
Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development. Exciting tasks are awaiting you: You will lead the Non-Conformity Management for purchased parts You assure compliance with our SOPs and external regulations during supplier qualifications and supplier related change management Your proactive approach ensures continuous improvements of process and product quality You coordinate
root cause analyses in multidisciplinary teams and apply your methodological skills You ensure quality through supplier audits Your profile: Bachelor's or Master's degree in engineering or technician with work experience.
Professional experience in engineering and/or quality management in the medical technology and/or automotive industry desirable Practical knowledge of FDA QSR, ISO 13485 and ISO 14971 Experience in the application of statistical methods Good Communication skills in German and English and assertive appearance Enjoying teamwork in an innovative and global work environment Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate
against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, interaction, interactionual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
Abiomed maintains a drug-free workplace.
in Aachen und Berlin, Deutschland, Tokio, Japan und Singapur. Abiomed ist Teil von Johnson & Johnson Med Tech. Abiomed ist ein Arbeitgeber mit attraktiven Arbeitsbedingungen und einer wertschätzenden Unternehmenskultur, bei dem die Bedürfnisse der Mitarbeiter im Fokus stehen.
Abiomed begeistert und bindet außerordentliche Talente durch Zusammenarbeit, Leidenschaft und kontinuierliche Weiterentwicklung. Als Hersteller innovativer Medizinprodukte zur Herz- und Lungenregeneration suchen wir für unser Qualitätsteam motivierte Quality Engineers (m/w/d) für die Bereiche Manufacturing Quality, Supply Chain Quality und Design Quality. Spannende Aufgaben warten auf Sie: Als Quality Engineer leiten
Sie das Non-Conformity Management über die gesamte Wertschöpfungskette. Sie verantworten die Einhaltung unserer SOPs und externen Regularien im Änderungsmanagement, sowie in der Prozess- und Lieferantenqualifizierung.
Sie koordinieren Ursachenanalysen in multidisziplinären Teams und wenden dabei Ihre Methodenkenntnisse an. Durch Ihr proaktives Handeln sorgen Sie dafür, das kontinuierliche Verbesserungen an Prozessen und Produkten umgesetzt werden. In Ihrer Tätigkeit führen Sie eigenverantwortlich interne Audits und Lieferantenaudits durch. Ihr Profil: Bachelor oder Master in Naturwissenschaften oder Ingenieurwissenschaften mit technischem Schwerpunkt oder Techniker mit Berufserfahrung
Berufserfahrung im Engineering und/oder Quality Management in der Medizintechnik (oder Automotive Industry) wünschenswert Idealerweise praktische Kenntnisse der FDA QSR, ISO 13485 und ISO 14971 Erfahrung in der Anwendung Statistischer Methoden Kommunikativ (Deutsch und Englisch), durchsetzungsstark Spaß an der Teamarbeit in einem innovativen und globalen Arbeitsumfeld Wir bieten: Angenehme, offene Unternehmenskultur mit einer starken Mission: " Recovering Hearts, Saving Lives" Umfassendes Einführungsprogramm mit strukturiertem Onboarding-Plan in der gesamten Orientierungsphase Zuschuss zur betrieblichen Altersvorsorge von bis zu 1.500, - Euro im Jahr und vermögenswirksame Leistungen Vorteilspakete für eine Berufsunfähigkeitsversicherung und eine betriebliche Gruppenunfallversicherung Komplette Kostenübernahme für ein Job Ticket im Raum Aachen oder Berlin Diverse Gesundheitsprogramme und Leasingmöglichkeit für ein Job-Rad ABIOMED ist ein Arbeitgeber, der Chancengleichheit vertritt.
Wir unterstützen die Chancengleichheit unserer Mitarbeiter ungeachtet der ethnischen Herkunft, der Hautfarbe, der Religion, des Geschlechts, der interactionuellen Orientierung, der Geschlechtsidentität, einer Behinderung oder der Nationalität.
phases company processes. Requirements: Bachelors degree in Quality Sciences, Engineering or comparative work in a technical field. 5-7 years of experience in Quality Management leadership and Quality Engineering in a manufacturing or process environment. Strong preference for quality-related experience in a manufacturing/foundry environment Demonstrated experience in the effective use of quality core tools (APQP, PPAP, FMEA, MSA, SPC, etc.
). Experience in deploying statistical quality methods (sampling plans, DOE, Cpk, etc. ) Understanding of metrology, with the ability to utilize several types of measuring devices such as calipers, micrometers, hardness testing, x-ray and coordinate
measuring machine (CMM). Experience with destructive and non-destructive tests on materials and parts to measure performance, life, or materials characteristics.
Ability to interpret engineering drawings, schematic diagrams or formulas and confer with management or engineering staff to determine quality standards. ISO9001 Quality Management System leadership experience. ASQ Quality Engineer certification a plus. Six Sigma Green or Black Belt Certified a plus. Experience with ISO14001, ITAR, AS9100, TS16942, ISO14981 quality systems. Experience with continuous improvement processes i. e. six sigma, kaizen, lean, etc. SALARY: $90-120K
of harnesses Perform inspection of first article and first piece inspections Aid in the trouble shooting of wire harness assemblies Follow compliance of AS9100 documentation requirements as applied to the wire harness production. Assist in the implementation and compliance of quality department initiatives, programs, policies, and goals.
Contribute in additional quality responsibilities as needed Knowledge, Skills, Abilities: Ability to read and understand technical drawings Mechanical aptitude and abilities preferred Experience with basic test equipment preferred Highly organized with ability to work in a fast pace environment Must have a positive attitude with a customer appreciation mentality Ability to lift 40lbs on a regular basis
Operational Excellence Principal Accountabilities: Compile statistical quality data including defects, product measurement data, and various metrics Maintain a Document Control system with collaboration of document owners Document changes to, and maintain the policies related to, the QMS Participate in organizational process improvement efforts Assist in providing guidance and training on quality best practices to teams across the organization Review customer and regulatory requirements, and provide guidance to the organization regarding compliance Assist in processing of returned material including status tracking and facilitating product return to customers Support in processing of Engineering
Change Notices Assist in verifying effectiveness of implemented Corrective Actions Manage Record Retention program including scanning and filing of various documents for record retention Provide solutions whenever possible Serve as back up to Production Documentation Specialist Additional work projects and responsibilities as assigned Required Skills: Previous experience with AS9100 or Quality in a manufacturing environment preferred Strong analytical and problem solving skills are required Highly organized and detail oriented Must be skilled and accurate in data entry and be proficient in Outlook, Excel, Visio and Word Strong interpersonal skills, including excellent verbal and written communication
skills Ability to perform multiple tasks effectively with a focus of timeliness and responsiveness Must have a positive attitude with a customer-appreciation mentality Bachelor's degree or related work experience required
