Pittsburgh, Pennsylvania | Contract
Pittsburgh, PA (north)
Currently have an opening in the north hills area of Pittsburgh, PA for a QA Technician.
In this role, the QA Technician will perform QA investigations and validation activities, as well as lead and manage the calibration program and preventive maintenance program to ensure compliance, and assist in performing internal audits.This role will also be responsible for CAPA coordination and managing the administrative tasks of the CAPA system. This person will assist in other areas of the quality management system in support of the quality manager
Essential Job Functions:
- Manage and execute the calibration program to make sure all equipment is available as required for production use and ensure department heads manage departmental equipment compliantly per required procedures
- Assist Engineering in determining new equipment requirements and needs, and incorporate the equipment into the Calibration and PM systems.
- Support Engineering as required to complete preventative maintenance
- Assist Engineering as required to perform process and product validation testing
- Perform, or assist in performing Internal Audits of Quality Management System processes
- Assist Quality Engineering in performing transfers of product inspection, test, and manufacturing equipment, processes, and records
- Assist in maintaining the internal audit plan and drive scheduling and compliance to ensure all requirements of the internal audit program are met.
- Perform duties as a CAPA coordinator and ensure Master Control CAPA system is current and properly maintained compliantly per defined CAPA procedures.
QA Technician Qualifications
- Associate's Degree in Electronics preferred.
- At least 3 years experience performing inspections and test within an FDA regulated environment.
- Knowledge of inspection/sampling techniques and familiarity with ANSI/ASQ Z1.4
- Familiarity with FDA QSR and ISO 13485 Quality System Requirements
- Knowledge of electronics assembly and test
- Knowledge of auditing to FDA QSR and ISO 13485 Quality System Requirements
- Detailed knowledge of mechanical and physical inspection techniques (calipers, micrometers, depth gauges, blueprint reading, CMM or optical comparator, burst test, seal strength, etc.)
- Good oral and written communication skills; Ability to communicate well with technical personnel
- Strong familiarity with computer applications such as Microsoft Outlook, Excel and Word
- Demonstrated strong attention to detail
ASQ Certification preferred
QA Technician - 14648