QA/QC Technician III
|Location:||MN - Minneapolis|
The QA/QC Technician performs various quality testing functions within the quality organization. The QA/QC Technician follows Standard Operating Procedures and detailed schedules and assignments. The QA/QC Technician documents their work per Good Documentation Practices to ensure data integrity and traceability. This position performs a variety of analytical and process functions. The QA/QC Technician follows internal policies and procedures in compliance with current FDA GMP policies/regulations, applicable ISO standards and AMS internal quality standards.
The QA/QC Technician will focus in one or more of the following disciplines:
Performs calibrations on manufacturing, R&D, and laboratory equipment. Maintains standards, supplies and materials. Prepares equipment and assists contract calibration technicians with internal calibrations. Reviews calibration certificates, and assists with Out of Tolerance Investigations. Works with teams to establish calibration methods for new equipment.
Receiving and Inspection
Performs inspection and measurement verification activities on incoming components and raw materials. Coordinates samples for testing at external contract labs and with the component services group. Sets-up and accurately operates testing equipment, Performs “First Article” Inspections and performs mold validations to assure parts are within defined specifications.
The Product Release Technician executes project tasks for the release to finished goods of new products and the processes to control product release. This individual works to improve the current product release systems and performs sterilization chart reading and quality hold with supervision from the Senior Microbiologist.
The Production Floor Quality Technician will execute the review of finished device paperwork and disposition any discrepancies. This person will initiate and close out product on the nonconforming materials process.
All positions are responsible for following applicable AMS policies and procedures as defined by their manager.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
* Essential Functions
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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