Quality Engineer

• Responsibilities may include the following and other duties may be assigned.
  
• Develops modifies applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  
• Devises and implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment.
  
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  
• May specialize in the areas of design incoming material production control product evaluation and reliability inventory control and/or research and development as they apply to product or process quality.
  

Requirements

Minimum 4 to 5 years of experience working in a regulated industry. Experience in CSV Process Validation and Equipment Qualification. Experience in Risk Management Documents (PFMEA). Bachelor Degree in Engineering Completed.

What are the top 3 things you are looking for in a candidates experience:

1. Experience reviewing and approving validation test plans reports and deviations
   
2. Capable of performing statistical analysis to support validations and product release
   
3. Knowledgeable of medical devices manufacturing regulations
   

Willing to work 100% onsite.