Quality Engineer

SNEHA JUKANTI

Email: ***********@*****.***

Phone: 951-***-****

SUMMARY:

Experience in Process Validation, Risk Management, Design of Experiments, Design Verification, Process Improvement and Quality Control in compliance with FDA regulations and Complaint Handling

Extensive experience with Design Verification, Process Validation and Test Method Validation

Hands on Experience in the remediation of Design History Files (DHF)

Expertise in developing and documenting all the aspects of Validation Master Plan (VMP), Installation Qualification (IQ)/ Operation Qualification (OQ)/ Performance Qualification (PQ), and Validation Summary Report (VSR)

Strong knowledge about pharmaceutical/medical device regulations/guidelines including 21 CFR Part 11, Part 210, Part 211, Part 820 and Annex 11

Experienced in validating test methods and processes utilized in the manufacturing of medical device products pertaining to medical device regulations including FDA 21 CFR Part 820 compliance and ISO 13485, 14971, 15223 & 15378

Thorough experience FMEA, Root Cause Analysis, Statistical Sampling and Statistical Process Control (SPC)

Strong experience in implementation of Change Management/Control and Corrective Action and Preventive Action (CAPA) procedures

Experience in gap analysis, continuous improvement and change control management

Strong understanding of 5S, Kaizan and Six-Sigma Principles

Experience with PLM systems using Agile PLM, CAPA Management through ENOVIA and Document Control using Livelink.

Hands on experience in DFMEA and PFMEA Analysis

Handled the BOMs and qualified the vendors and suppliers

Experience in performing risk assessment, Risk Management and Gap Analysis

Strong understanding of Six-Sigma Principles

Lean and Six Sigma training/experience

Production Part Approval Checklist (PPAC), First Article Inspection (FAI), and Incoming Inspection Record (IIR)

Well versed with monitoring tools- IQS, Matlab, Minitab

Initiated and implemented CAPA Procedures and Processes

Created Risk Management Plan and executed it

Reviewed Risk Management Documentation and approved them

Excellent communication skills along with verbal and written skills

Technical Skills:

Manufacturing Process Development & Optimization Tooling & Fixture Design Design Control Design Input/ Output Design V&V MRP ISO cGMP Assembly Operations Time Studies Capacity & Layout Planning Quality Assurance DOE Six Sigma PFMEA SPC Minitab –– CAPA Metrics - Root Cause Analysis Data Analytics GD&T Kaizen Lean SCAR - JIT 5S VSM Corrective Action/Preventive Action – Design and Operational Qualifications - Validation Plan – Risk Management Plan- FDA Regulations - Closing Nonconformance Reports (NCR) & Nonconformance Material Reports (NCMR)

WORK EXPERIENCE:

Zimmer Biomet, Warsaw, IN Sep 2014 – Present

Manufacturing Quality Engineer

Responsibilities:

Reviewed Installation Qualifications (IQs), Performance Qualifications (PQs) for various validation projects for Compression molding and Polymer Machining.

Created Process Validation Plans, Process Maps, Process Requirements, pFMEA, protocols and reports for IQ, OQ, PQ, and MVP's for remediation of process and equipment.

Worked actively and experienced in Design Verification.

Reviewed Statistical Sampling plans.

Worked actively within Analytical Testing Services (ATS) at the client site.

Worked extensively on Infinity QS for Process Monitoring and Trending.

Reviewed testing protocols for Tibia Metals and Poly components for Knees.

Evaluated suspected or out-of-specification (OOS) test results, reportable values, obtained during the performance of laboratory testing for release of product, in-process evaluation, acceptance, stability, validation/qualification, or other regulatory requirements within Analytical Testing Services.

Analyzed organic and inorganic compounds to determine chemical and physical properties, composition, structure, relationships, and reactions, utilizing different techniques.

Assured safe and proper handling in the Lab and evaluation of risks associated.

Improvement, development and customizing products, equipment, formulas, processes, and analytical methods.

Wrote ZTPs (Zimmer Technical Protocols) for ATS lab testing which included total carbon tetrachloride extractable Analysis, TOC analysis, water extractable analysis, debris analysis and Cytotoxicity studies.

Quality disposition of Gage Rejection Notifications (GRNs).

Approved First Article Layouts (FALs) in Production.

Managed and supported CAPA investigations using Company's CAPA process

Reviewed/analyzed complaint data to identify issues that warrant CAPA investigation

Created and approved NCRs and performed root cause analysis.

Reviewed NCMR and CAPA-designed and deployed systems for complaint handling and resolutions.

Resolved customer corrective actions to implement solutions.

Assessed effectiveness using the appropriate statistical sampling methods.

Quality disposition of orders on hold in production.

Handling Operator certifications and vision tests.

Ensuring no defective product goes out of production and placing different types of quality holds.

Changes and updates to Zimmer work instructions (ZWIs) to ensure better quality.

Orthofix, Lewisville, TX Sep 2012 – Aug 2014

Quality Engineer

Responsibilities:

Planned and implemented validation activities as they relate to both development and commercial products.

Extensive experience with Process Validation.

Created supplier inspection documents such as Production Part Approval Checklist (PPAC), First Article Inspection (FAI), and Incoming Inspection Record (IIR).

Authored Master Validation Plan (MVP), IQ, OQ, PQ documents, Process Verification/Validation Plan (PVVP), and Test method validation reports.

Performed Supplier Audits and determining inspection type based in Supplier Quality risk assessment.

Additional Development of inspection characteristics, gauging techniques and sampling requirements.

Originated Production Part Approval Process (PPAP), including Part Submission Warrant (PSW), Control Plans, Process Flow Charts and Failure Mode and Effect Analysis (FMEA)

Planned, Coordinated and direct programs designed to ensure quality of products consistent with established standards.

Reviewed all data obtained during all quality assurance activities to ensure consistency with company policies and procedures.

Investigated and adjusted customer complaints regarding quality.

Continuously develop and improved the adequacy of existing Quality Assurance procedures and processes.

Facilitated the CAPA process to ensure that the investigations are thorough, identified the appropriate root cause(s) and implemented effective action(s).

Investigated Nonconformance and came up with corrective and preventative actions to prevent the issue from occurring again

Tracked and reported progress for each CAPA

Performed and assisted internal and supplier quality audits

Addressed customer quality issues, returns, complaints, etc

Promoted a culture of quality awareness

Directed inspection of products to company, supplier and/or customer activities

Provided Quality support on implementation of design controls on a new project

Performed root cause analysis and implement corrective actions

Developed plans that bring together the information on projects, resources timescales monitoring and control

Participated in Military Audits and inspections

Played an active role on quality management teams within the organization

Interpreted Quality Assurance Philosophy to key personnel in the organization

Sanmina, Huntsville - AL Dec 2010-Aug 2012

Quality Engineer

Responsibilities:

Developed Verification/Qualification deliverables including Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports.

Interfaced with manufacturing in developing new process to maintain that the processes are capable of producing products according to ISO 9001:2000 standards.

Reviewed and approved Engineering Change Request (ECR) and Engineering Change Notice (ECN)

Performed root cause analysis and implement corrective and preventive actions.

Represented the Quality Department on Process Improvement Teams (5S and Kaizen).

Reviewed and created Production Part Approval Process (PPAP); including Part Submission Warrant (PSW), Control Plans, Flow Chart and Failure Mode and Effect Analysis (FMEA).

Coordinated quality procurement and inspection requirements for suppliers and plants.

Supported MRB activities.

Directed preliminary reviews of non-conforming materials and process.

Performed and directed source and in-process inspections.

Performed Test Method Validation (TMV).

Ensured that manufacturing instructions (visual work instructions) include relevant complete and accurate quality requirements.

Directed inspection of products to company, supplier and/or customer activities.

Coordinated government and customer source inspection activities.

Provided direction to the inspection staff relative to technical interpretations.

Analyzed reports for returned products and recommends inspection corrective actions.

Performed and written validations of processes and equipment in accordance with FDA and ISO guideline.

Designed, executed, and analyzed experiments based on statistical techniques

Developed, troubleshoot, and refined medical device manufacturing processes and equipment

Conceptualizing and instituting improvements to a medical product and its manufacturability

Developed and carried out performance tests on a device to characterize and document its safety

Modeling the effects of the physiological environment on medical devices

Validated the Test Fixtures, Test Assemblies and Gauges.

Created RM Plan and RM Report in compliance with QSR 820 and ISO 14971.

Reviewed the Design History Files (DHF).

Established programs and solutions for increasing uptime and for equipment problems that affect the packaging process to include customer-defined issues.

Evaluated and sourced equipment and new technologies to aid in process optimization.

Performed GAP Analysis and also developed the corresponding Remediation plan.

Assisted in investigations for non-conformances providing guidance for root cause and CAPA.

Education:

Masters in Industrial Engineering, Cleveland State University

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