Quality Engineer

The Quality Engineer will provide quality assurance support to the product development team, resolving bugs, defects, and other potential issues and ensuring that products meet customer specifications. 

Job Responsibilities 

• Operate within Good Manufacturing Procedures (G.M.P) regulations and guidelines always in accordance with ISO13485. 
• Comply with all Standard Operating Procedures (S.O.P’s)  
• Comply with the requirements of the Quality Management System and relevant standards 
• 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 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. 
• Reviews and approves validation protocols and final reports for equipment, product, and processes. 
• Resolution and continuous improvement for root causes analysis, including NCE and Compliance. 
• Investigates manufacturing and customer non-conformance's (complaints) through root cause analysis. 
• Develops and implements corrective action necessary to resolve NCE/CAPA issues. 
• Conducts effectively 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. 
• Other duties as assigned. 

Required Skills/Abilities  

• Excellent verbal and written communication skills.  
• Excellent organizational skills and attention to detail. 
• Extensive knowledge of or the ability to quickly learn the organization’s production processes. 
• Excellent interpersonal skills with ability to serve as a liaison with developers, project managers, and customer support. 
• Strong analytical and problem-solving skills. 
• Proficient with Microsoft Office Suite or related software. 

Education and Experience 

• B.S. in Engineering, Engineering Technology, Science is required. Or 
• Minimum of 1-2 years Quality Engineering related experience and/or training is required. 
• Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred. 
• Experience in an FDA regulated environment is preferred. 
• Corrective / preventive action (CAPA): 1 year preferred
• Knowledge of regulations and industry applicable standards (ISO 13485, FDA CFR820, GMP, ISO11135).  
• Knowledge of process improvement and other statistical process methods. 
• Knowledge of process and product validations. 
• Experience in healthcare industry and/or manufacturing industry is desired 

Physical Requirements 

• Prolonged periods of sitting at a desk and working on a computer. 
• Must be able to lift up to 35 pounds at times.  

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.