Quality Engineer - Indotronix Avani Group : Job Details

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/or BD associates to assure compliance with all BD 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 and complexity, using policies and procedures for guidance.

Minimum of 3-5 years of experience for QE II and 5-7 years for Sr. QE in Medical Device, Biotech or Pharma Industry.

Strong knowledge of 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)

Hands on experience using Six Sigma methodology