Sr Instrument QC Tech

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