Quality Engineer I - Reagents

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