Srujana Anna aduxpj@r.postjobfree.com

952-***-****

Professional Summary

Experienced Quality engineer professional in the regulatory industry with a wide range of experience in Manufacturing, Operations, lean & continuous improvement activities

Experienced in working with cross-functional teams and hands-on experience in GMP system qualifications (review/approval Lifecycle documentation, IQ, OQ, PQ, etc.) to ensure compliance with applicable QMS requirements, policies & procedures

Proficient with Microsoft Office, including Word, Excel, Visio, PowerPoint, and Outlook

Understanding of Quality Management Systems (ISO 13485), Risk Management (ISO 14971), cGMP, 21 CFR 820, MDR, EU regulatory compliance

Specialist in all areas of technical and content management development, SOP (Standard Operating Procedures), Methods & Procedures, review and submissions, process improvement, safety & risk management/analysis, CAPA, NCMR, complaint handling, process mapping, data flows, regulatory, compliance, controlled documentation development

Professional Experience

Abbott, Minnetonka, MN Jun 2020- Till Date

Quality Engineer II

Monitored product line performance and reported on the current status and potential improvements through research and root cause analysis

Reviewed, updated, and maintained all quality documentation(including specifications, SOP, Shop floor paperwork/DHR) to ensure quality

Responsible for daily Quality Engineering support of manufacturing operations where daily activities require working with collaborative cross-functional team.

Timely resolve the issues on the production line and take appropriate action.

Point of contact for quality issues for Aveir, Pacel and His pro product lines

Gemba walks to maintain quality presence and pulse on ramp-up efforts

Issue Evaluation (IE), Evaluation of Non-Conforming Product (NCP), timely closed NCMR, and supported CAPA activities.

Worked on validation activities, including planning, characterizing, statistical sampling plans, Gauge R&R, PFMEA generation, data normality analysis, IQ/OQ/PQ execution, deviation remediation/mitigation, and Cpk/Ppk analyses for manufacturing processes

Worked on quality activities which included document/change control (ECN) incoming inspection, calibration, final product inspection/test, complaint handling

"Back Room" general for internal audits and onsite FDA inspections

Provides support to manufacturing and incoming inspection areas, aiding to ensure a product with the highest quality

Performed investigation of product non-conformance, root cause analysis, monitoring/trending of process and product, and escalation of identified issues

Troubleshoot equipment and process issues, disposition of non-conforming material requiring advanced process/technical knowledge, interface with cross-functional teams to resolve process issues and execute corrective and preventive actions.

Terumo Medical Corporation, Elkton, MD Aug 2017- May 2020

Quality Associate

Integrating Engineering R&D, Quality Engineering, Failure Analysis and testing to all Product Surveillance Quality and Manufacturing products & procedures.

Evaluate existing manufacturing equipment, and processes for line transfer between sites

Author/ execute & wrote process validations (IQs/OQs/PQs)

Plan and execute Gage R&R study to determine part variations and complete test method validation

Assist, devaluate and analyze PFMEA

Apply six sigma principles to investigate root-cause failures

Evaluated test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives

Provide training to employees regularly as to update their knowledge in quality processes.

Reviewed all open Supplier Corrective Action Records (SCARs) for appropriate effectiveness

Collaborate to complete Component Qualification and document evidence

Provided support with the creation of protocols, work requests & reports for supplier-qualified components

Assisted the supply chain functions with qualifying and monitoring outside manufacturers and suppliers

Collaborated with suppliers to collect evidence and develop the Production Part Approval Process (PPAP)

Supported drafting Supplier Validation Master Plans (SVMP) and managed the activity tracker. Documented and reported the trends to the management weekly, monthly, and quarterly

Terumo Medical Corporation, Elkton, MD Aug 2015- Aug 2017

Quality Technician

Duties involved all aspects of production, assembly, machine operation according to the ISO procedure

Performed daily random audits of finished products and audit to verify reworked/sorted products

Communicated appropriate information to supervision and other employees

Co-ordinated/assisted in developing and maintaining all regulatory compliance documentation, including work instructions, SOP’s and routers/shop floor paperwork

Supported the Control of the Nonconforming Material process and Corrective & Preventive Action (CAPA) process

Identified areas of improvement and participate in continuous improvement projects

Assisted with qualification and validation (IQ, OQ, PQ, TMV)

Education

Master of Business Administration from Kakinada University

B.COM. from Acharya Nagarjuna University

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