Requirements

Bachelor’s degree in Engineering: mechanical, electrical, chemical, bioengineering or related area and 2+ years of experience in medical device industry. Familiarity with CFR 21 part 820, ISO13485. Proficient in Microsoft Excel and good working knowledge of computer programming and systems. Knowledge of PQ, TMV, AQ, NPSV validations. Exposure to Gamp5 or similar regulations.

Job Description

The Quality Assurance Engineer for Beckman Coulter Diagnostics is responsible for completing Process validation deliverables for Diagnostics, Life Science and Urine Analysis Business units. It will also ensure integrity of products manufactured and shipped out to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards. This position is part of the Miami Process Validation Group and will be located in Miami/Hialeah traveling between sites. The engineer is part of the Miami PV and reports to the Senior Manager, Process Validation. They will work with senior QA staff and be responsible on instrument manufacturing responsible for Process Validation & QA Instrument Shared services. Write and conduct IOQ, and spreadsheet validations. Complete PQ, TMV, AQ as well as NPSV validations. May manage process and product non-conformances in line with company procedures. Develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards.