The overall role of the Quality Inspector/Technician is to inspect parts and assemblies to applicable requirements; to troubleshoot technical situations and help drive corrective actions as appropriate. Individual must be able to work independently with minimal guidance and supervision.
- Perform receiving, in-process, first article, verification of labeling, parts sampling and final inspections on assemblies, subassemblies, and finished products to determine conformance with applicable source control drawing specifications, workmanship standards; and record inspection status on applicable quality control (QC) records.
- Conduct and document process and system audits using written procedures as audit standards.
- Provide assistance to Managers and Engineers for projects related to research and development, production technology, and quality control.
- Compile and record data and prepare graphs, charts, and reports to support various activities. These may include quality records, nonconformance reports, inspection reports, training records, equipment maintenance logs, continuous improvement initiatives, corrective action reports, validation, and test results.
- Vocational training, AA degree required, BS preferred. Completed coursework in quality-related programs preferred.
- Previous experience as quality inspector or technician in FDA-regulated facility preferred.
- Prior experience in medical device production/development preferred.
- Knowledge of basic mathematical skills, including statistical functions and experience applying same in manufacturing and laboratory settings required.
- Ability to read and understand prints & drawings, dimensions and tolerances, BOM parts lists, specifications and other technical documents.
- Total Quality Management (TQM), 5S, 6 Sigma, Lean, and 8D training and experience helpful.
- Working familiarity with MS Office Products required.
- Demonstrate good time management, planning/organization, and decision-making skills.
- Excellent communication skills and the ability to interface with individuals at all levels and functions of the business. Ability to interface with contacts both inside and outside of the organization.
- Ability to work well in teams with others from other organizational functions and backgrounds as an individual contributor or facilitator.
- Medical Device Experience Required
Ulthera, Inc - 2 years ago