Syeda A Batool

*** ***** **. ********, ** *****

Phone : 201-***-****

adxtfl@r.postjobfree.com

SUMMARY:

* ***** ** ********** ** the quality Engineer responsible for analysis, evaluation and product investigation of complaints received from external customers with respect to business objectives, root cause analysis, quality plans, Supported On-Time Products Release, Incoming Receiving Reports documentation. Understanding of current Good Manufacturing Practice (cGMP), Good Documentation Practice (GDP), and ISO requirements. Responsible for implementation of CAPA systems designed to meet or exceed internal and external requirements.

TECHNICAL SKILLS:

Complaints Handling and Investigations, Root Cause Investigations, Risk Management, CAPA, Product Testing, DHR, Root Cause Analysis, Control Plans, Gage R&R, SPC, NCMR, SCAR, FMEA, Quality Control Plans, Statistics, Quality Audits.

Education

Bachelor’s in industrial Engineering

University of New Jersey Institute of Technology (NJIT)

Associate in Engineering science

Essex County College Newark

Course Work

Work measurements and standards Engineering Cost Analysis and Control

Supply chain and production planning Engineering Management

Product quality assurance

Work Experience

Johnson & Johnson ( Design Quality Engineer) Jan 2022- Present

Design Quality Engineer

Assist product development and supply quality teams with design requirements, verification testing methods, and helping to ensure the team is in compliance with applicable processes and regulations

Coordinating failure investigations with engineers and suppliers, seek SME as require and participate in preparing failure investigation and analysis reports, Lead DFMEA, DTM for new and existing product

Responsible supplier training on new technology

Review and approve all testing and design output, including design verification and validation

Recommending, planning and leading assigned corrective and preventative actions for continuous improvement, supporting design and process changes for current product and provide input and approval of qualification protocols and reports, leading or participating in risk management activities following ISO 14971 with the tools appropriate for various stages of the product lifecycle including DFMEA, PFMEA

Carry out audits to ensure compliance company requirements Participate in Supplier Quality harmonization activities as new sites/businesses are acquired

Designs or specifies inspection and testing mechanisms and equipment; conducts quality engineering tests; and analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications

Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements

Reviewed regulatory documents including analytical reports, process validation reports, raw material, and finished product specifications, and stability data to ensure compliance with various agencies prior to submission for approvals

Successfully completed complex engineering work in the following areas: product design and development, test method creation and validation, component and device specification generation, process analysis and documentation, and design control documentation

Escalated complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encountered

Documented nonconforming product according to the Corrective and Preventive Action System (CAPA).

Support areas of design control, process controls, verification /validation, production control, product evaluation and reliability as they apply to product or process quality

Abbott ( Quality Assurance Specialist ) Feb 2020 - Nov 2021

Quality Complaints Specialist

Responsible for providing support and investigation of customer complaints for commercial products and supporting continuous improvement of commercial products. Interfaced with customers regarding the details and documentation of complaint records, investigation, and risk management

• Responsible for analyses, evaluation and product investigation of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR), and other regulatory guidelines.

• Performed detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts). Implement corrective and preventative actions.

• Wrote the investigation reports, verify the effectiveness of previously implemented CAPAs and track and trend deviations.

• Conducted product testing, including testing to support complaint investigations and stability verification

• Performed risk assessment, root cause analysis, corrective, and preventive actions.

• Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.

• Experience with CAPA processes (e.g., complaints, nonconforming product) and root cause investigation techniques (e.g., 5 why, fishbone).

• Performed complaint investigation and prepared complaint investigation reports,

• Maintenance of complaint handling site procedures and compiled various complaints metrics.

• Conducted incoming quality inspections, new product release inspections, production and rework jobs, and nonconforming and damaged product inspections.

• Conducted post market testing, shipping and receiving of consumer devices.

• Ensured that testing and documentation are performed according to GMP and GDP practices.

• Conducted root cause analysis to determine the true root cause of all deviations.

• Ensured timely, accurate and complete complaints and failure investigations of returned products. Ensured timely closure of complaints to comply with FDA requirements and other regulatory bodies and countries.

• Responsible for product investigation of post market device complaints in compliance with regulatory guidelines.

• Assisted in complaint investigation and prepared complaint investigation reports, assigned test on retention, and returned samples and wrote customer letters.

• Performed retention, decontamination and testing of returned devices. Performed data analysis, additional testing, simulation testing, and root cause investigations and resolution in support of a thorough complaint investigation related to product quality and patient safety.

• Ensured timely, accurate and complete complaints and failure investigations of returned products.

WinCo Jan 2019-Nov 2019

Quality Assurance Specialist

Identify gaps in efficient process workflow and suggests steps for supplier quality process improvement.

Collect, prepare and analyze data for corrective action and process improvement.

Support production operations and critical business situations.

Ensure materials and products meet defined product specifications and standards.

Provide clear direction for change and assists in change management.

Document the results of all inspections.

Review, compile, and analyze information to prepare reports.

Utilize data monitoring tools to highlight analysis priorities.

Accept responsibility for own safety and that of others.

Assist in defining and improving processes as part of a team.

Responsible for the revision or development of new material specifications.

Investigate quality issues to identify root causes and ensure issues are addressed and resolved.

Performed failure investigations identify potential causes of failure, document investigations and evaluations performed.

Analyze all customer feedback for trends and continuous improvement.

Prepare and present materials/findings both internally and externally.

Skills

Proficient using: Microsoft Excel, Word, PowerPoint, Publisher & Access.

Knowledge: Auto Cad, Mat lab, and Arena.

Languages

• English

•Urdu/Hindi

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