Senior Quality Engineer

Responsibilities

• Interaction with both suppliers and customers on quality problems 
• Collection and analysis of  data from both within the factory and in the field
• Risk assessment
• Validation activities – creating and reporting IQ/OQ/PQ
• Internal and Supplier audits and assessments
• Supervision of the activities of two incoming inspectors
• Management of the CAPA process
• QMS training and maintenance of training records

Requirements

• BS Mechanical, Electrical, Chemical Engineering or similar field
• 10 + years of manufacturing and/or quality experience, preferably in the medical industry
• Experience with ISO 13485 60601.
• Strong statistical background.  Fundamental understanding of sampling plans & AQLs
• Successful writing and reporting of IQ/OQ/PQ validations