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Job Title: Quality Engineer (Job # 6692) | Apply Now
Job Description: The Sr. Quality Engineer will be responsible for the quality assurance during the development of new products and the associated transfer into manufacturing. This position will also support the ongoing operations of existing manufacturing. This will include document review of: Process Travelers, Material inspections, and Tooling and Equipment. This position includes quality system activities such as initiation of Nonconformance reports, Deviations, updating and maintaining of quality documents and assisting with audit preparation. This position will report to the Quality & Compliance Manager.
" Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
" Identify requirements for verification and validation and reliability testing.
" Develop product Design History Files (DHR), Technical Files, Device Master Records (DMR), and FMEAs.
" Provide quality review of process validation and test method validation protocols and reports.
" With Regulatory, ensure all documentation meet the requirements of Regulatory Filings and Technical files for CE filings.
" Provide statistical guidance to test protocols/reports and ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
" Plan schedule and complete projects in an aggressive sense of urgency manner consistent with corporate objectives.
" Provide quality review of manufacturing documentation, including following lot release procedures for shipping product to customers.
" Education- Master's or Bachelor's Degree in engineering or related field
" 5 years minimum experience in medical device or pharmaceutical industry
" Ability to understand specifications, tolerances, and units and use standard measurement equipment
" Familiar with QC sampling plans
" Knowledge of FDA, GMP, and ISO 13485 compliance requirements
" Familiar with the product life cycle of medical device development
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