What are the responsibilities and job description for the Quality Engineer II position at Indotronix Avani Group?
Job Title : Quality Engineer
Location : San Diego, CA
Duration : 12 Months
The Quality Engineer II is accountable validation execution for manufacturing equipment and support in process validation or verification studies. Successful performance requires close work with quality management, operations, suppliers and associates to assure compliance with quality policies, procedures, and practices.
Must demonstrate a working understanding of the ISO 13485 Quality Systems Regulations on Class I / II / II products. Preferred core experience in Quality Assurance, Quality Control, Validation (IQ,OQ,PQ) and Nonconformance management for regulated devices(i.e. : Good Manufacturing Practices, ISO, FDA). Proven ability to develop solutions to a variety of problems of moderate scope.
Education and Experience :
BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field
Minimum of 5 years of experience for QE II and 5-7 years for Sr. QE in Medical Device or Pharma Industry.
Experience with Process Validation and equipment validation .
Strong understanding and knowledge on ISO 9001, ISO 14971 and / or ISO 13485 ( Design Control , Supplier Management and Risk Management)
5. Hands-on experience using Six Sigma methodology
