Position Summary

This is a full-time exempt position. The Quality Engineer I is responsible for assisting with the maintenance of technical aspects of the Quality Management System, including investigations, validations, corrective actions, risk management, and continuous improvement efforts. This person will be working with bioMerieux employees outside of Quality Assurance on a day-to-day basis and must have a customer focused attitude. The person represents Quality Assurance on complex technical and process issues. They are an advisor to assist resolving problems where they support specialty experts and guide process compliance.

Schedule: 4X10s Monday-Thursday. Every fifth week Sunday-Wednesday.

Primary Duties

• Performs all work in compliance with company policy and within the guidelines of the bioMerieux Diagnostics, LLC Quality System

• May support the NCR, CAPA, validation and risk management systems to ensure the following:

• Relevant procedures and requirements are considered and applied

• Timely completion of support activities

• May assist teams with investigation methodologies and validation strategies

• Assist team with notes, action item recording and follow through, and communication to senior leaders as needed.

  Qualifications

  Training and Education

• Required – Bachelor’s Degree in a Science or Engineering discipline. Minimum ten years professional experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system may be considered in lieu of a degree.

• Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.

  Experience

• Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlines below

• Previous experience in an Engineering, Scientific, or Investigative role is preferred.

• Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is preferred.

• Application and use of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, 8D, etc.) a plus.

  Knowledge, Skills, and Abilities

• Fundamental understanding of problem investigations (identification, scope determination, impact assessment, and remedial action)

• Technical writing skills

• Writing procedures, flowcharting

• Ability to collaborate cross-functionally

• Application of Quality Risk Management principles

• Attention to detail (e.g. document reviews, investigation write ups).

• High level of written and verbal communications skills

• Ability to communicate with Statisticians and perform statistical calculations as instructed.

• Wisdom to seek help when needed.

• Proficiency in MS Office tools, including Outlook, Word, and Excel

  Physical Requirements

• Ability to remain in a stationary psotion, often standing, for prolonged periods