The Quality Engineer will be responsible for creating and revising inspection procedures and test plans for products, components and equipment. The Engineer will be responsible for documentation and investigation of product and process nonconformance, including product complaints. Additionally the engineer will be responsible for managing inspection and validation documentation. The Engineer will report to the Quality Manager.
Responsibilities will include:
• Preparation of Incoming, in-process and Final inspection procedures and sampling plans
• Maintenance of NCR system
• Preparation of Quality trending reports for parts usage, product defects and Supplier Quality
• Preparation and execution of ECN, including manufacturing routings and BOMs
• Participation in Internal and Supplier audits
• Working with QA Manager in complaint investigation and CAPA
• Working with QA Manager for equipment and process validations
• Preparation and maintenance of new part numbers, bills of materials and routings.
• Participate in product development
• Prepare testing protocols and execute as necessary.
• Create inspection documentation per design requirements
• Prepare verification/validation protocols and reports related to products and processes
• Perform statistical analysis of data against design specifications
• Setup and manage document control procedures and processes
• Support efforts for any internal auditing needs
• Additional responsibilities can be added as required
BS degree in an Engineering related field or equivalent. 3-5 years work experience in medical device manufacturing in a quality role is required. Working knowledge of ISO 13485 / FDA 21 CFR 820 / cGMPs, AQL sampling plans and statistical analysis are required. Lead Auditor certification a plus.