The Quality Inspector 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.
Primary Duties and Responsibilities:
Perform inspections of purchased parts, subassemblies or finished company product according to well-defined criteria using standard physical, mechanical, and/or electrical measurements
Accurately document the results of inspections and testing
Conduct and document process and system audits using written procedures as audit standards
Maintain all controlled document files and test records in a timely and accurate manner
Coordinate calibration of all test equipment and fixtures
Perform data entry into associated data systems. SAP knowledge preferred
Monitor critical equipment and instrumentation to ensure proper operation and calibration.
Participate in the construction and/or revision of SOPs for the inspection function
Participates in construction and/or revising inspection procedures, protocols, and checklists
Evaluate problems and make initial recommendations for possible corrective action to the supervisor
Skills/Requirements
High School graduate or equivalent required. AS in a technical field preferred
4 years experience in quality inspection. Medical device experience preferred.
Extensive knowledge in Geometric Dimensioning & Tolerance preferred
Extensive knowledge in IPC – 610 preferred
Ability to use all inspection gages and electrical test equipment
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
Strong ability to perform complex mechanical inspection (may assist engineering with problem solving, fixture design and setups)
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 Employment Opportunity/Affirmative Action employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.