Sr. Quality Control Technician - Campbell, CA
This position is responsible for the throughput of incoming inspection and product testing while ensuring applicable product/component quality control specifications are met. Assist the company in maintaining compliance to regulations, procedures, and work instructions.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
Preparing inspection plans and coordinating the completion of inspections to meet production demand.
Conducting inspection and testing following controlled procedures and test methodology.
Performing final product acceptance testing.
Record and analyse the inspection and testing data to determine if acceptance criteria has been met.
Review completed production lot history records to ensure completeness and good documentation requirement have been met.
Perform production line audits to ensure process steps are being followed by the production staff.
Initiate/Address Quality Control Issues
Initiate nonconformances when inspection criteria failed to meet specifications.
Ability to describe and detail observed defects.
Assist in the disposition activities for nonconforming material.
Participate in investigations and root cause analyses for identified issues and recommend improvements.
Coordinates the calibration and preventative maintenance schedule for equipment in the quality control laboratory.
Assist in the qualification and installation of inspection/testing equipment
Proactively supports continuous improvement and lean manufacturing processes
Makes/implements recommendations for quality system improvements
Document Control & Filing
Responsible for the completion of and storage of inspection records.
Assists with maintaining electronic and hard copy logs used for assigning document numbers, tracking current document revisions, tracking document changes and releases, tracking externally referenced documents and standards, and tracking the locations of controlled documents
Assists in training team members or peers on test methods and inspection methodology.
Maintains personal training compliance in accordance with company policy.
May assist in complaint investigations with a focus on returned device evaluation and production record review.
High school education and a minimum of 5 years quality control work experience in the medical device industry.
Experience working with catheters, endovascular or neurological devices (preferred)
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 (both written and verbal)
Must be able to perform multiple tasks concurrently with accuracy
Proficiency with Microsoft Office products
If you are interested in applying, please call Tom Cooper at 408-452-8747 Ext.5354, or click the “Apply” button.
United States of America
Engineering / Engineering
Direct Hire Position
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Job Title: Sr. Quality Control Technician
Location: Campbell, CA
Job Type: Direct Hire Position
Reference ID: 343986
Posted Date: 10/19/2018