Quality Technician/Document Coordinator

Help to ensure compliance to Quality System in areas of responsibility (primarily Doc Control and Inspection) by generating, updating, maintaining Quality System documentation, procedures and forms, as requested or needed
Maintain quality system records in accordance with established procedures
Initiate and review documentation and product change requests
When necessary initiates and investigates (Nonconforming Material Reports) NCMR's and or Corrective and Preventive Actions (CAPA) for system or product/process deficiencies
When necessary, assists in Design and Manufacturing Engineering activities including Design Failure Modes, Effects & Criticality Analysis (dFMECA), Product Failure Modes, Effects & Criticality Analysis (pFMECA), verification and validation, design reviews, phase reviews, document reviews, DHF Audits, etc.
Supports all related departments and Suppliers to resolve process and material related issues
Monitors supplier performance, and initiate corrective actions and conducts remote and on-site audits (once trained) and as required
When requested, works directly with suppliers to prevent or correct discrepant material, and assist suppliers in developing inspection methods
Classify and code documents according to specified system
Assign cross-indexing attributes if subject matter should be classified and filed under more than one heading
Placing material in electronic media for manipulation and storage
Locate, remove, and/or modify material from files when requested
Keeping electronic records current
May revise documentation and organization system to improve usage
AA degree or higher preferred
At least 2 years' experience in medical device, pharmaceutical, or biotech industries in an Inspection, Quality Technician, Documentation Control or related role preferred.
Knowledge of ISO 13485 and FDA QSRs preferred
Experience in document control, organization, calibration and inspection practices
Certified Quality Technician or Auditor is a PLUS

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