bioMérieux is a World leader with over 45 years in the field of in vitro diagnostics. We develop, produce and market diagnostic systems for medical and industrial application. Scientific and technological innovation is at the heart of bioMérieux's strategy. Our solutions (reagents, instruments and software) are used to determine the source of disease and contamination to improve patient health and ensure customer safety.
To fulfill our mission to improve public health worldwide, bioMérieux is present in more than 150 countries through 39 subsidiaries. Our world headquarters are located in the Lyon area in France.
Come join our team as a Senior Quality Engineer! We are committed to creating an optimal work environment that fosters teamwork, emphasizes training, and offers international career development opportunities. Our compensation plan is highly competitive with an added rich benefit package, including 4 weeks PTO, Medical, Dental, Life, LTD, STD and 401K plan matching.
• Bachelors degree in a scientific or technical field with 5-7 years of relevant industry experience.
• Competence in the selection and use of Quality Engineering Tools and Techniques.
• Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.)
• Participate in regulatory and agency inspections, audits, investigation and inquiries regarding the control and assessment of product design and manufacturing quality
• Document quality systems and programs in the areas of management responsibility, auditing, quality trends, quality costs, training, validation, design controls, purchasing controls, corrective and preventive actions, process control, customer complaints, calibration, documentation control, etc. to ensure compliance with FDA, and regulatory requirements.
• Coordinate facility CAPA program
• Ability to work independently and in a team environment
• Mentor and support the training programs (QSR/ISO, Auditing, Root Cause Analysis)
• Certified Quality Engineer (CQE)
• Communicate to internal/external - verbally and written
• Certified Manager of Quality / Operational Excellence (CMQ/OE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) or Six Sigma Black Belt (CSSBB) desired.
This opportunity will be managed by Novotus. If this position seems like a good fit for you, please apply through our online process and a Novotus Representative will be in touch with you soon with the next steps.