Sr. Quality Inspector - Catheters

Cirtec Medical Corporation•Santa Clara, CA

71d•$24 - $32•Onsite

About The Position

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, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records and equipment calibration. This is not a remote position.

Requirements

High school diploma or GED
5 years 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 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 PCs and Microsoft Office software applications

Nice To Haves

Experience in catheter inspections
Equipment management, such as calibration and preventative maintenance

Responsibilities

Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
Indicate inspection status of parts with assigned labels and stamps.
Maintain product identification and traceability.
Control non-conforming product 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 Cirtec 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 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 function of the job.

Benefits

training and career development
healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid Time Off and 401(k) retirement savings with a company match

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