Crown Technical Staffing is looking for an experienced Senior Quality Engineer to work with our client in the heavily regulated industry of medical device manufacturing. The ideal candidate will review and approve validation protocols and final reports for small medical device products and processes. This person will Investigate manufacturing and customer complaints through root cause analysis (RCA) and provide support for new product development. This is an on-site role reporting into the facility of a leading medical device manufacturer in South Atlanta. This is a full-time, direct-hire opportunity with full benefits and relocation bonus offered for the right candidate.

Primary Responsibilities of the Senior Quality Engineer:

• 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) 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.
• Formulates responses to customer complaints.
• Facilitates improvement projects and teams.
• 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.
• Participates 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.
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Develops product specifications and sampling plans.
• Establishes a program to evaluate the precision and accuracy of 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.

Qualifications for Senior Quality Engineer:

• Bachelor’s Degree in Engineering, Science or related technical field
• 5 – 8 years of Quality Engineering experience with increasing responsibilities
• Experience in medical device manufacturing, aerospace and defense, electrical components, or food and beverage industry is a MUST
• Validation and/or new product development experience is a MUST
• Knowledge of QSR, ISO 13485, CFR 820, and EN regulations.
• Knowledge of process and product validations.
• Experience in the development of Measurement Systems Analysis, GR&R, and Test Methods. 
• Experience with supplier/Internal Audits