Cirtec Medical Corporation-posted 13 days ago
$24 - $32/Yr
Full-time • Mid Level
Onsite • Santa Clara, CA
101-250 employees
Miscellaneous Manufacturing

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.

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