Quality Engineer

• The Quality Engineer will be responsible for Consistent application of Quality system standards to assigned Quality system area

• Developing solutions to routine assigned activities of moderate scope & complexity, following applicable Company’s Unit procedures, updating procedures and policies when required, working within and across functions for assigned Quality systems

• Quality project management, data summary, interpretation, administration and maintaining a working knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements.

• BS degree in Quality or Life Sciences, Engineering (Biology, Chemistry, Microbiology,) 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.)

• Must have experience with ISO 13485 and 21CFR 820 Quality Systems

• SAP experience preferred. 

• Auditing experience preferred

Kind Regards

Ricky

732-429-1925