Principal Quality Engineer Jobs

Extensive experience as a Software Quality Engineer, Design and Development Quality Engineer with experience in the FDA design controls and risk management System Development Life Cycle (SDLC), familiar with Waterfall, V-shape model, and agile mode also Experience in Statistical Process Control (SPC) Methodologies and best practices.

·Experience in multiple SDLC methodologies, IQ/OQ/PQ/TMV/Software Validation in system & quality and Solid command of technologies, tools, and best practices in Testing, Verification & Validation activities, Technical Documentation (IQ/OQ/PQ) in Compliance to FDA regulations, Risk Analysis SME (DFMEA, PFMEA).

·Strong knowledge of SDLC by FDA requirements and ISO standard 62304; strong experience with validation documentation URS, FRS, SDS, IQ, OQ, and PQ follow Compliance regulatory requirements. conducting Acceptance testing, Ad Hoc testing, Beta testing, Compatibility testing, remediation, End-to-End testing, Recovery testing, Functional testing, Regression testing, Integration testing, performance testing, Load/Stress testing, Smoke testing, and System testing in the validation of IOS (software and hardware) and project management in Share point.

PROFESSIONAL EXPERIENCE

Software Quality Engineer

• Performed eQMS database(s) and Computerized Maintenance Management (CMMS) systems, Software Development Life Cycle (SDLC), Software verification and validation including a training program for relevant disciplines to participate in the evaluation of vendor Quality Management Systems (QMS) to meet business objectives.
• Managing testing starting from protocols to review of reports from verification and validation engineers which act as design quality engineer’s extended team with Compliance to Quality Management System and Design Controls in Risk Management, Report (RMR) all AFAP (As Far as Possible)/High risks are adequately addressed from the DCRM and Production Risk Management (PRM/PFMEA) documents.
• Managed audits, including planning, supervising, conducting, following up, and supporting auditing techniques in a QMS environment with Computerized Maintenance Management (CMMS) systems completed review and revision of the Complaint / CAPA system to align with Software Development Life Cycle (SDLC), FDA, cGMP, 803, 806, MDD, CE, EU requirements and provides technical remediation guidance and support.

Education

• Master’s in engineering management