Sr Quality Control Technician
$79,000–$86,000 year
On-site · Campbell, California, United States
Job Summary
Senior Quality Control Technician responsible for preparing inspection plans, coordinating product inspections with Manufacturing Inspectors to meet production demand, conducting inspections and testing per controlled procedures, recording and analyzing data against acceptance criteria, reviewing production lot history and lot disposition documentation, performing production line audits, initiating nonconformance processes, assisting in disposition of nonconforming material, participating in root cause investigations and improvements, coordinating calibration and preventive maintenance of QC lab equipment, supporting qualification and installation of inspection/testing equipment, driving continuous improvement and lean manufacturing, and implementing quality system enhancements using knowledge of FDA and ISO quality standards. Strong emphasis on attention to detail, multi-tasking, and clear communication within a medical device manufacturing environment.
Required Qualifications
- A minimum of 4 years of quality control experience in the medical device industry; or equivalent combination of education/training and work experience
- Experience working with catheters, endovascular or neurological devices
- Working knowledge about quality system requirements (FDA 21 CFR Part 820 and/or ISO 13485), as they relate to quality control processes and good manufacturing practices
- Strong communications skills (written and verbal)
- Strong ability to perform multiple tasks concurrently with high level of accuracy
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