Description
Summary of essential job functions- Performs QA documentation reviews, with signature authority, for Device History records, Receiving Inspection forms, Returned Goods Authorization, etc.
- Maintain Corrective Action Board (CAB) and Corrective Action Report program in accordance with FDA QSR, MDD and ISO 13485:2003 requirements.
- Oversees and standardizes CAPA charting, trending and reporting.
- Performs internal audits covering all aspects of the ISO13485 elements, EN46001, MDD, and FDA regulations, including Quality System Regulations and relevant areas of Title 21 in order to support the Internal Quality System Audit program.
- Provides administrative / technical support to the Associate Director, Quality Assurance in the performance of investigations on reported product failures, adverse events or field complaints in accordance with FDA, MDD, and ISO 13485 requirements.
- Assists in the review, tracking and trending of all returns (Product Non-Quality and Product Quality) in accordance with company returns policies and regulatory requirements.
- Data input into the computer system for data collection purposes used to identify quality trends.
- Perform Change Order processing and release activities.
- Maintain Change Order log and coordinate approval process as required.
- Communicate change order information and interface with Manufacturing, Engineering, Quality, Clinical and Research & Development.
- Support Finished Good Inventory label development and control.
- Provides assistance in ensuring that departmental records, Quality Management System procedures, specifications, corporate standards, external standards (e.g. ISO 13485, Vigilance) comply with FDA Quality Systems Regulations (QSR's) and applicable foreign regulations (e.g. Medical Device Directive).
Minimum requirements:
- Associate's degree (AA) or equivalent from two year college or equivalent combination of education and experience. Bachelor's degree preferred.
- Three to Five years' experience in medical device or pharmaceutical/ biotech industry, with working knowledge of FDA and ISO regulations.
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