Senior Quality Control Tech

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.

• 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.

• 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).

• 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).

• Consistently upholds and reflects the core ethical principles and values that bioMerieux 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 clear, timely information to ensure alignment.
• Troubleshooting issues to identify and resolve problems efficiently
• Critical thinking, using logic and reason to analyze information and make decisions in the workplace.
• Advanced: demonstrates deep knowledge; manages complex tasks and integrates multiple tools independently
• Ability to complete projects with limited supervision in a timely fashion

This position impacts the manufacturing life cycle Quality Control for products produced in St. Louis. Failure to properly execute Quality Control inspections, tests, or analyses on the part of this position could directly result in a product recall. Operating within clearly defined guidelines, is empowered to make decisions impacting product quality, quality records, deviation resolution, and site compliance.

• Ability to ascend/descend stairs, ladders, ramps, and the like: Yes
• Ability to wear PPE correctly most of the day: Yes
• Ability to adjust or move objects up to 50 pounds in all directions: Yes
• Must be able to push a wheeled cage that can weight up to 600 lbs.
• May operate within cool temperatures and low humidity.
• Constant noise is common due to equipment.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [emailprotected].

BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).