Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
I Am Abiomed | I Am Heart Recovery | Patients First!
The Quality Inspector II will perform inspections, checks, tests, review of quality documents such as a device history report and sampling procedures of incoming materials, parts/components, partially assembled or finished medical devices. Provide support as needed to the Operations group.
NOTE: This is a First shift role.
Principle Duties and Responsibilities:
• Perform inspections on mutliple and varied purchased parts, subassemblies or finished product according to well-defined criteria using standard visual, physical, mechanical, and/or electrical measurements
• Perform visual inspection on large lots size under a microscope.
• Perform mechanical inspection using advanced inspection systems which included using a vision and or touch probe system
• Perform electrical and optical cable and sensor testing
• Crossed trained in all inspection steps for purchased componets and finished product
• Accurately document the results of inspections and testing
• Maintain all controlled document files and test records in a timely and accurate manner
• Perform data entry into associated data systems.
• Monitor critical equipment and instrumentation to ensure proper operation and calibration.
• Identify problems and make initial recommendations for possible corrective action to the supervisor
• High School graduate or equivalent required.
• 2 plus years experience in quality inspection. Medical device experience preferred
• Ability to read critical dimensions on component drawings and Article Specification
• Knowledge in Geometric Dimensioning & Tolerance preferred
• Knowledge in IPC – 610 preferred
• Ability to use all standard inspection gages, electrical test equipment and microscope
• Knowledge in ISO and GMP. US FDA 21 CFR QSR and ISO 13485 preferred
• Attention to detail with the ability to follow SOPs inspection procedures
• Ability to perform complex mechanical inspection
• Strong math and verbal/written communication skills
• Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives a plus.
• Ability to execute tasks in a timely manner under general supervision.
• Computer literacy required. Working knowledge of Microsoft Office Suite, MRP system; SAP knowledge desired
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, sexual 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.