Position Summary

Conducts activities within the Quality Control functions of Incoming Inspection of components and raw materials (ensuring that materials meet specifications), In-Process audits (ensuring that manufacturing operations remain in control), and the inspection and release of finished product, as appropriate. The job entails ensuring equipment is maintained / calibrated as appropriate, departmental documentation is current and accurate. Responsible for ensuring deviations are properly documented, nonconforming material is segregated and secured, and the supporting of any projects assigned. Performs all duties using safety conscious practices. Individual must inspect/test/audit materials & processes in a timely fashion while, at the same time, ensuring conformance to all requirements.

Primary Duties

• Performs a wide variety of inspection, audit and release activities.
• Written procedures, blueprints, standards and regulations that define requirements assume a significant degree of experience and understanding on the part of the QC Technician of inspection techniques, appropriate inspection equipment, principles of sampling, data analysis, auditing, and the theory of operation and function of the various instruments.
• Inherent in the process of inspection is the interpretation of requirements, and the need to use careful judgment to determine compliance. It is critical for individuals in this role to use sound judgment and demonstrate consistent decision-making.
• Performing the QC testing routinely results in the need to investigate nonconformances, and either independently address them, or interface with technicians and/or engineers to diagnose and remedy the problem.
• Understands operational priorities, “hot parts” lists, and the daily/weekly instrument production schedule to meet the needs.
• Responsible for the timely setup and inspection of components, raw materials, in-process, and release of finished product in accordance with specifications. Interprets blueprint requirements and confirms conformance to specifications. Leads in the standardization and advancement of inspection methods. Train new and existing QC Technicians.
• Maintain's thorough knowledge of the transactions in the ERP system for movement of materials.
• Transport conforming parts to inventory, including all computer transactions and written record completion. For materials found to be nonconforming, generates “nonconforming material reports”, requiring a technically accurate description of the anomalies.
• Responsible for ensuring nonconforming, Line Throw Off, and Purged material is segregated and secured including the disposition of non-conforming materials meet all necessary site and regulatory requirements.
• Perform Quality Control in-process inspections & audits necessary to support Instrument Manufacturing. Assesses subassemblies, finished devices, and the assembly & test processes for conformance to documented requirements.
• Perform final inspections of completed medical devices and accessories, including the detailed review of the Device History Record package to confirm the completeness and accuracy of records prior to formally releasing the instrument for distribution.
• Execute complex First Article Inspections.
• Responsible for ensuring that QC Inspection Methods are current and accurate.
• Maintains thorough understanding of all specifications, requirements, and procedures and provides input regarding the continuous improvement of each.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Qualifications

• High School Diploma, GED or equivalent
• 4+ years of related experience in a Quality Control setting having competence in the use of Quality Dimensional Tools and Techniques and advanced knowledge of quality systems (SAP/LIMS/Trackwise).

Preferred Qualifications

• Must have an advanced knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
• Expert ability to use precision mechanical measuring instruments, coordinate measuring machine, optical comparators, microscopes, measure scopes, meters and other various electrical test equipment. Expert ability to read and interpret complex blueprints, a plus would be the knowledge of Geometric Dimensioning & Tolerancing (GD&T).

Knowledge, Skills, and Abilities

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Effective verbal communication skills
• Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
• Informing others by sharing c