Medical Device Quality Inspector at Ryzen Solutions

JOB SUMMARY

This position is primarily responsible for performing receiving, first piece, in-process, and final inspection or test on a wide variety of parts and document results. Indicate inspection status, and maintain product traceability and non-conforming material control. Participate in internal audits, and statistical process control, and assist in control of process documentation, records, and equipment calibration.

ESSENTIAL RESPONSIBILITIES

• Inspect, measure and/or test incoming parts, production first piece, in-process, and final product, record results, and notify appropriate personnel.
• Indicate the inspection status of parts with assigned labels and stamps.
• Maintain product identification and traceability.
• Control non-conforming products in accordance with documented procedures and verify timely corrective and preventative action.
• Protect product during handling and storage in the performance of work.
• Monitor factory environmental conditions, record data, and alert adverse conditions.
• Assist with distribution and control of process documentation and quality records.
• Assist with control of measuring and test equipment calibration.
• Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
• Assist with statistical methods of verifying and controlling process capability.
• Provide input when required to quality planning for specific projects and products.
• Provide leadership to production personnel on quality issues.
• Comply with and reinforce the requirements of the Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations, and other customer standards.
• Follow Occupational Safety and Health regulations, including laser safety practices.
• Other agreed duties within the Quality Department are consistent with training, qualification, and experience.
• Provide Quality Support for the disposition of discrepant material.
• Provide Quality Support as needed for product transfers from development to production.
• Provide leadership to production personnel in relation to quality.
• Interact with Quality Engineering to resolve CAPA investigations and in support of Manufacturing.
• Document and issue inspection plans.
• Provide Quality Control support to Manufacturing & Engineering.
• Coordinate and prioritize the daily activities of Quality Control in the absence of the Department Supervisor.
• Monitor inspection results for shifts & trends.
• Reliable, consistent, and punctual attendance is an essential job function.
• Complies with company, quality, safety standards, policies, and procedures.
• Other duties as assigned.

QUALIFICATIONS

• High school diploma or GED
• 5 years of minimum experience in manufacturing, preferably medical devices, with increasing responsibility and a regulated environment.
• Certificate/s of training related to this field of work (medical or quality assurance)
• 5 years of experience as a Quality Control Inspector
• Must be able to read, write, and speak fluent English
• Proven experience in inspection and documenting results
• Able to demonstrate competence in interpreting technical drawings & specifications
• Proficient in the use of microscopes, measuring, and test equipment
• Able to check dimensions, squareness, hole locations, surface relationships, finish material defects, and mechanical strength of product following appropriate training
• Have experience in the use of PC’s and Microsoft Office software applications