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Quality Engineer - Instrument Manufacturing.

Company: Biom--rieux
Location: Saint Louis
Posted on: September 15, 2018

Job Description:

A strong Scientific and technological pioneering spirit drives bioM--rieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bioM--rieux commitment to public health. bioM--rieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety. Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products.We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities.A strong Scientific and technological pioneering spirit drives bioM--rieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bioM--rieux commitment to public health. bioM--rieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety. Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products. We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities. Responsible for the implementation and maintenance of effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations. To participate and provide guidance to quality improvement teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement. Ensures products (including services) are developed, manufactured, tested and delivered according to established procedures that will assure that they meet all quality requirements. The incumbent must be cognizant of the effects of changes to regulatory requirements (e.g., new revisions to ISO 9001, ISO 13485, country specific regulations, etc.) on the facility Quality Management System and ensures compliance to these regulations and standards. The incumbent will develop quality programs to facilitate continual improvement actions. 1. 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.2. Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality3. Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained4. Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, etc.5. Specify and develop special inspection equipment, fixtures, and procedures in conjunction with manufacturing6. Ensure that the disposition non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent reoccurrence.7. Quality Engineering Support for Design Control Process -Develop and implement project Quality Plan (as necessary), review and approve to Design Specifications, Design verification and validation protocols, facilitate and participate in design reviews, develop quality-engineering deliverables and assure Design History File (DHF) is updated (as necessary)8. Executing Internal/Supplier Audits.9. Participates in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis. Coordinates implementation of corrective actions and preventive measures.10. Supports continuous improvement projects.11. Develop and establish statistical sampling plans for validation, incoming inspection, etc.12. Develop and execute training programs (e.g. change control, GMP, risk analysis, statistics, etc.)1. Bachelor's Degree with 3-5 years work experience or equivalent experience in related industry, preferred degrees: BSME, BSEE or BSIE.2. Competence in the selection and use of Quality Engineering Tools and Techniques.3. Ability to work independently and in team environment4. Ability to effectively communicate written and verbally5. Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.)6. Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt desired. bioM--rieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender IdentityTo apply:

Keywords: Biom--rieux, St. Louis , Quality Engineer - Instrument Manufacturing., Engineering , Saint Louis, Missouri

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