Quality Assurance Engineer

Ranfac Corporation is a Medical Device Manufacturer in Avon, MA. We have an opening for a Quality Assurance Engineer who will provide assistance by working with Quality, Manufacturing and Engineering.

Responsibilities include:

• Assistance in maintaining ISO 13485:2003 and FDA QSR compliant Quality System.
• Work closely with QC  Inspectors by providing technical support to address Non-Conformances and resolve Corrective and Preventive Actions in manufacturing or with suppliers.
• Develop and update quality plans for new and existing product lines by working with the necessary departments to determine the criteria.
• Contribute to the resolution of CAPA’s, NCMR’s and Supplier Corrective Actions.
• Work with Engineering to develop and conduct validations, IQ/OQ/PQ plans and appropriate test methods and acceptance criteria.
• Conduct FMEA / Risk Analysis and develop Technical Files for new/existing products.
• Develop and Revise Standard Operating Procedures, Production and Quality Procedures

Qualified candidates should have 2-5 years experience in Quality Assurance with a Medical Device Manufacturing company. This experience should include statistical techniques, sampling plans, blueprint reading, metrology skills and the ability to work with others. Understanding of regulations pertaining to FDA & ISO is required. Good oral and written communication skills as well as project planning skills are required. Must be proficient in using Microsoft Office and Windows PC applications.