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Quality Assurance Manager
1 month ago
Reviews and approves validation protocols and final reports for equipment, product, and processes.
Resolution and continuous improvement for root causes analysis, including Non-conformance Reports (NCR), Supplier Corrective Action Requests (SCAR), and Compliance.
Investigates manufacturing and customer non-conformances (complaints) through root cause analysis (RCA).
Develops and implements corrective action necessary to resolve NCR/CAPA issues.
Conducts effectivity checks for all root cause analysis, CAPAs and document findings.
Assist in investigating customer complaints.
Assists in improvement projects and teams, including experiment design and data analysis.
Interacts with customers and suppliers routinely to ensure that product quality is constantly maintained. Addresses all product quality issues for current products. Oversees and maintains all quality functions related to packaging and manufacturing.
Assisting in FDA inspections, ISO audits, and customer audits of the plant quality system.
Performs supplier and internal audits, generates audit reports, and manages responses.
Develops and initiates standards and methods for inspection, testing, and evaluation.
Assists in creation of sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
Develops product specifications and controlling documents such as artwork and drawings.
Establishes program to evaluate precision and accuracy or production equipment and testing, measurement, and analytical equipment and facilities.
Develops and implements methods and procedures for disposition and discrepant material and devises methods to assess cost and responsibility.
Direct workers engaged in measuring and testing products and tabulating data concerning materials, product, or process quality and reliability.
BS in Engineering, Science or related technical field
3-5 years Quality Engineering related experience and/or training is required.
Knowledge of QSR, ISO 13485, CFR 820 and EN regulations. (highly desired)
Knowledge of process improvement, SPC and other statistical process methods.
Knowledge of process and product validations.
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