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