Faye Eshragh Email & Phone Number

Acton, Massachusetts, Us

Acton, Massachusetts, Us

Acton, Massachusetts, Us

lead Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and for automated data processing systems used as part of the quality system.

San Diego, Ca, Us

Provided software design quality assurance and ensure external and internal quality system requirements are adhered to throughout product and process lifecycles.• Performed risk assessments and validation assessments for product and process software changes. • Identified gaps, suggested solutions and led enhancement to software validation procedures, processes and practices.• Authored, and reviewed computer system validation documents, including validation plans, risks assessments, IQ/OQ, URS/FRS, PQ, test scripts, trace matrix, final summary reports for analytical instrumentation ensuring GxP and data integrity requirements are maintained.• Mentored and leaded other test engineers and provided technical guidance as necessary during validation activities.• Supported a team through investigations and corrective actions for software related CAPAs and Internal Audits. • Responsible for ensuring compliance to Alere quality policies and procedures.• Maintained and continually improved Software Quality System procedures representing best practices and GMP, ensuring that the procedures meet all applicable regulatory standards and requirements.

Franklin Lakes, New Jersey, Us

Test lead for clinical analytics software applications developed in support of Infusion Pumps from project conception through delivery to the market.• Led team of software test engineers in Design Control processes and ensured software quality across deliverable by performing system, functional, performance testing of medical devices.• Managed all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.• Closely followed and maintained QMS processes and procedures• Hands-on experience working under the guidance of 21 CFR 820 ,21 CFR 11 and ISO 13485. • Collaborated closely with Program Managers to ensure design deliverables were met and could be released.• Collaborated with developers for quick turnaround of issues. Met project deadlines.• Coordinated cross-functional activities with team leaders to ensure issues were resolved and devices were of the highest quality while meeting business goals.• Derived continuous improvement efforts, through facilitating, leading, and collaborating with cross function teams. • Identified areas requiring quality improvement and initiated and followed through plans of action necessary for next version implementation.

Ca, 92121, Us

• Performed smoke, sanity, core regression and feature regression testing on new released builds to find their readiness for further testing by test team• Reviewed software requirements and developed functional and system test cases based on these requirements.• Verified defect resolutions provided by the software development team.• Reported defects observed during the various phases of the software testing with detailed analysis and logs.• Validated software risk mitigators function correctly by testing at the system level.• Utilized in-house test platforms and various software tools during the verification and validation of in- house IVD products.• Worked with team members to continually expand on and improve the Software quality and release processes.

San Diego, Ca, Us

San Diego, California, Us

San Diego, Ca, Us

• Designed hardware and software for several video transmission products.

Kista, Stockholm, Se

Montreal, Qc, Ca

Bs, Computer Science

Engineer, Bs, Electrical (Telecommunication)

Certificate, Cisco Certified Network Associate Program (Ccna)

Certificate, Computer System Validation (Csv)