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Pharma/Medical Device/Bio Technology : Quality Engineer : Canaan, CT

Lancesoft Inc
Canaan, Connecticut, 06018, United States
March 21, 2017


Education and Experience• BS degree in Life Sciences, Engineering (Biology, Chemistry, Microbiology, Electrical, Mechanical, Software/Computer Science) and a minimum of 5-6 years of experience in Pharmaceutical/Biotechnology Industry required. • Professional certification is preferred (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, SQE-Software Quality Engineer, CQM- Certified Quality Manager, etc.). • SAP experience preferred.


The Quality Engineer will be responsible for working closely with other functions within the organization (Manufacturing, R&D, Quality, Engineering, Procurement, Marketing) and ensuring the quality of the product and processes for the assigned product line(s) are in compliance with standard Quality practices. The QE will develop, modify, apply and maintain quality standards and protocols and may also be responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements. Responsible for developing, documenting and/or maintaining design history files.