Major Duties and Responsibilities
Responsibilities will include, but not be limited to:
- Inspect/test components as part of incoming inspection. Use common QC inspection tools such as micro-balances, calipers/micrometers, pin gages, rulers, thickness gages, thermometers, timers, vacuum/pressure gages, optical measurement machines
- Perform quality review of Lot History Files (LHRs)
- Maintain files for equipment requiring validation, calibration and preventative maintenance. Coordinate activities with internal resources and approved service providers for calibration and maintenance activities
- Perform calibration, maintenance, and training on select equipment
- Perform CER monitoring activities (line clearance, particulate testing)
- Support Quality engineering in management of complaints
- Support the maintenance of training records.
- Perform verification, validation, and lot release testing of development and production devices
- Enter data into MS Excel and perform prescribed data analysis
- Assess issues of moderate complexity independently and implement solutions
- Maintain work area cleanliness and compliance with various safety, fire and hazmat guidelines
- Execute work in a manner which is compliant with FDA and ISO guidelines for medical device development and manufacture
- Provide feedback to management on quality system effectiveness for areas supported
- Create and implement process improvements aligned with organizational objectives and the Quality Policy
Qualifications
Experience
- Minimum 5 years of relevant Quality experience in the medical device industry
- Performed finished goods product release testing (QA activities)
- Performed incoming inspection (QC activities)
- Knowledge of cGMPs, cGLPs, ISO, ASTM, FDA regulations, and applicable standards
- ASQ Certified Quality Technician (CQT) desired
- Ability to communicate effectively with external and internal customers verbally and in writing
Education Requirements
- AA degree preferred
This position is based in Milpitas, CA and is an onsite position. The salary range is $38.50 – $45.50 per hour based on factors including experience, skills, etc.
Apply Now
- AA degree preferred
This position is based in Milpitas, CA and is an onsite position. The salary range is $38.50 – $45.50 per hour based on factors including experience, skills, etc.