Quality Engineer

Quality Engineer – Windsor, CT

Responsibilities:

•         Maintain the quality management system, resolve issues and support continuous improvement.

•         Identity and address sources of process variability to optimize processing conditions of equipment.

•         Identify main causes of processing issues and take actions to correct them.  

•         Conduct investigations and determine disposition or returned good. Interact with customers to identify the best option for unused, damaged or defective products.

•         Investigate and resolve customer complaints

•         Lead and support the product commercialization process.

•         Establish systems that verify process equipment accuracy and integrity.

•         Establish equipment calibration systems in compliance with ISO standards. 

•         Insure compliance with state, federal and international regulation and standards such as FDA, ISO2200, ISO 9001 and 13485.

•         Document and evaluate manufacturing and converting equipment and process parameter trends to improve processes.

•         Provide training as needed.

•         Provide guidance and assistance to other technical service engineers when needed.

•         Practice disciplined development process by applying PFMEA and DFMEA and established ASP system.

•         Provide technical support to product lines, customers and suppliers.

Requirements:

•         Bachelor’s degree

•         2+ years of experience in technical service, process control, quality engineering, product development or related technical experience.

•         Knowledge in PC and working experience in spreadsheet, word-processing and statistical analysis.

•         Knowledge and experience in FDA requirements, ISO standards, HACCP and auditing techniques.

•         Ability to work independently with minimal supervision.

•         Ability to make decisions on quality engineering, process control and product commercialization issues and resolve internal and external technical issues.

•         Statistical process control training- desirable.

Posted
09/01/2021
Type
Full time
Location
Windsor, CT 06006, US