Quality Manager | Mason, IA

Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.

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.

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