Instrument QC Tech-Incoming QC

POSITION SUMMARY

Conduct QC 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. Responsible for ensuring deviations are properly documented and nonconforming material is segregated and secured. Performs all duties using safety conscious practices. Individual must inspect/test/audit materials & processes in a timely fashion while 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, 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. Consistent decision-making is required.
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.
7. 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.
8. 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.
9. 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.
10. 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.
11. Execute basic First Article Inspections.
12. Responsible for ensuring that QC Inspection Methods are current and accurate.
13. Maintains an understanding of all specifications, requirements, and procedures adequately to provide input regarding the continuous improvement of each.

KNOWLEDGE, EXPERIENCE & SKILLS

1. Associates technical degree is a plus and two years of hands on Quality Inspections experience preferred
2. Ability to effectively communicate written and verbally.
3. Requires strong interpersonal skills to interact with all levels of the organization and consistent decision making. Also requires a solid analytical approach to decision making and problem solving.
4. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
5. Must have an knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
6. Experienced in the use of precision mechanical measuring instruments, coordinate measuring machine, optical comparators, microscopes, measure scopes, meters and other various electrical test equipment.
7. Experienced in the ability to read and interpret complex blueprints, a plus would be the knowledge of Geometric Dimensioning & Tolerancing (GD&T).
8. Ability to work with limited supervision and to complete tasks in a timely fashion.