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Sr Instrument QC Tech

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Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Position Summary:
Conduct 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. Ensure equipment is maintained / calibrated as appropriate, departmental documentation is current and accurate. Ensure deviations are properly documented, nonconforming material is segregated and secured, and the supporting of any projects assigned. Perform all duties using safety conscious practices. Inspect/test/audit materials & processes in a timely fashion while, at the same time, ensuring conformance to all requirements.
 
Primary Duties:
  1. Perform a wide variety of inspection, audit and release activities.
  2. 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.
  3. 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.
  4. Perform QC testing which 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.
  5. Understand operational priorities, “hot parts” lists, and the daily/weekly instrument production schedule to meet the needs.
  6. 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.
  7. Train new and existing QC Technicians.
  8. Maintain thorough knowledge of the transactions in the ERP system for movement of materials.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. Execute complex First Article Inspections.
  14. Responsible for ensuring that QC Inspection Methods are current and accurate.
  15. Maintains thorough understanding of all specifications, requirements, and procedures and provides input regarding the continuous improvement of each.

 

Position Requirments:

High School Diploma required with 7 years of work 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).

Technical Degree preferred.

Ability to effectively communicate written and verbally.

Requires strong interpersonal skills to interacts with all levels of the organization. Also requires a strong analytical approach to decision making and problem solving.

Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).

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).

Ability to work with limited supervision and to complete projects in a timely fashion.

Ability to be a representative in groups of peers from production, engineering, R&D, and quality

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux 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 [email protected].

BioMérieux 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 BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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