Bio Merieux Work Values

Daily Duties at Bio Merieux:

Implemented regulated activities to Calibration Program throughout several bioMerieux sites: Lombard Chicago, Durham N. Carolina, and Saint Louis Missouri. Managed over 120 Field Service Engineers and their test equipment, ensuring compliance with both customer and FDA requirements. Managed the Saint Louis Preventive Maintenance Program, including documentation and departmental representatives performing PM tasks. Project Leader in making bioMerieux, Inc. 21 CFR Part 11 compliant. Maintained Quality System Functions. Adhered to FDA, ISO 9001, 14971 and BSI 13485 requirements by verifying the effectiveness of corrective and preventive action programs. Assisted in the documentation of quality systems and programs in the areas of auditing, training, corrective and preventive actions, customer complaints, and documentation control to ensure compliance with FDA, and regulatory requirements. Participated in internal audits, reviewed the results to ensure resolution of any noted deviations. Implemented preventive and corrective actions to verify the effectiveness of audit trailing. Initiated and implemented changes to procedures, policies, and specifications that made department more time efficient. Experienced in Validation and Verification on new software introduced to bioMerieux, Inc. in accordance to FDA and ISO regulations. Suggested new organizational data base software, which lead to a $50,000.00 savings. Rewrote and presented new Process Risk Analysis procedure, policy and procedure is now corporate wide. Performed Instrument, software, and disposable Validations. Worked with Logistics department to ensure cold chain requirements were met. Involved in contract negotiations and vendor selection. Revised budget activities in the 2007 Calibration Program saving 20% of $350,000.00. Managed day to day business functions within Materials Department. Coordinated all shipping, receiving and production support materials movement. Forecasted and planned material based on projected sales and previous trends and capacity availability. Controlled accounts and planed all aspects of inventory management. Managed 10 direct reports, providing guidance, performing reviews, and trained accordingly. Participated in the development of cellular manufacturing in warehouse, which lead to reduction of overtime by $25,000.00. Certified in Dangerous Goods regulations, IATA and ICAO. Supervised staff of twelve employees, conducted quarterly and annual performance reviews. Consistently met the needs of both internal and external customers. Improved and maintained inventory with net worth over $10 million dollars. Implemented new ways of warehouse efficiency, which lead to $100,000.00 savings in labor and material cost. Certified and familiar with: HAZMAT, OSHA, ISO, FDA, GMP, CGMP, QSR, TQM and MRP regulations, guidelines and procedures. Acted as team player in implementing and training on new inventory control software (MOVEX).

What they like about Bio Merieux:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

Medical Device, Quality Engineer, ISO

Skills

P&L responsibilities, Presentation, Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts., Technology Solutions, Sales Support, Software Implementation, Requirements Analysis & Specification, Leadership

These are some of the questions we asked our climbers about their experiences with Bio Merieux: