Quality Control Technician
Job location: Tucson, AZ
Ensure that finished devices consistently meet required quality standards based on documented requirements.
Inspect all incoming materials for use in manufacturing of medical devices, evaluate quality of materials and determine acceptance or rejection of these items based on documented requirements.
Inspect purchased items and subcontracted parts and sub assemblies intended for use in medical device manufacturing processes or systems based on documented requirements.
Inspect finished goods and release to inventory based on documented requirements.
Document and communicate results of acceptance activities per approved and applicable quality system procedures, forms and/or other documents.
Ensures that the Quality System is compliant with 21 CFR 820, 803, 806, ISO 13485 and CMDR.
Support activities concerned with development, application, and maintenance of Quality standards for manufacturing processes, materials, and products.
Assist/perform in Developing, implementing and coordinatization methods and procedures as well as associated forms for disposition of discrepant material and non-conforming products and processes.
Assist in organizing and conducting supplier audits as part of the supplier selection and approval process and supplier management quality system.
Support the inspection and disposition of incoming materials, including purchased items and subcontracted parts and sub-assemblies for use in manufacturing of medical devices.
Ensure device history records are in compliance with procedural and regulatory requirements prior to release of finished goods.
Shipping of goods
Quality and Business Systems:
Identify solutions and/or complete assigned tasks related to resolution of corrective and preventive actions, internal audit findings and non-conformance reports.
Schedule and provide assistance to complete critical tasks required to maintain the Quality System e.g.: calibration, particulate monitoring, etc. Update processes and methods as needed to improve the effectiveness of the systems.
Monitor, trend and evaluate results of quality monitoring processes including bioburden, pyrogen and NCR trend data. Evaluate and investigate as necessary results of monitoring process and communicate the information in appropriate formats including basic statistical summaries and trend charts.
Monitor supplier status and communicate any change in status to the finance, quality and operations department heads. Generate and maintain approved supplier files, including audit documents and supplier performance metrics.
Provide assistance and guidance to manufacturing, quality, purchasing and receiving personnel in the execution and routing of controlled documents for approval in the electronic document management system.
Identify and implement changes to quality system documents per existing change control procedures to improve document clarity or enhance compliance of the document to procedural and/or regulatory requirements.
Maintain quality documentation files for device history records, suppliers, calibration, maintenance, internal audits, environmental and product monitoring activities.
Education, experience and training
Associate’s degree, or equivalent preferred
Three to Five years’ experience, of applicable industry preferred
Training in FDA QSR, ISO 13485:2003 and CMDCAS desired
Basic computer skills, i.e. Word and Excel