SUMMARY:

• A Non - Conventional thinker and Engineer with work experience in manufacturing and product development with Data analytics skills in Process and Quality Improvement and optimization.
• In depth knowledge of FDA regulations like 21 CFR Part 11, 21 CFR Part 820, 210,211 and other SOX, GxP (GMP, GCP, GLP, GDP) regulations and GAMP5 guidelines.
• Strong knowledge and experience in developing Master Validation Plan (MVP), Process Failure Mode Effects Analysis (PFMEA), Qualification Documents (IQ, OQ & PQ), Validation Summary Report (VSR) and Requirements Traceability Matrix (RTM).
• Zimmer Biomet trained and practical experience in understanding Geometric Dimensioning and Tolerance (GD&T), cGMP and application.
• Experience with initiating and tracking quality investigation in TrackWise system, handling of CAPA related to products and update in TrackWise system.
• Competent in Quality System and Standard (cGLPs, cGCPs, and cGMPs), 21CFR (Part 11, QSR, Gap Analysis and Remediation Plans.
• Good experience in 21 CFR Part 11 tool kit. Reviewed projects to determine regulatory and compliance impact.
• Profound knowledge medical device regulations like FDA 21 CFR Part 11, FDA 21 CFR part 820 and ISO 13485.
• Equipment validation and Technical documentation as per FDA/ISO 13485 and GAMP regulations.
• Experience in authoring and reviewing Qualification documents (IQ, OQ & PQ), Standard Operating Procedures (SOPs) to be compliant as per FDA Regulations.
• 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.
• Performed Risk Assessment using Process Failure Mode effect Analysis (pFMEA) and Risk Management File (RMF).
• Engineered projects within automotive and medical manufacturing environment by project planning skills.
• Working knowledge of Lean Manufacturing and Lean project management with a vision to improve the product and process.
• Working knowledge on APQP/PPAP for Medical devices supplier components to enhance supplier quality.
• Working knowledge on Data analysis skills and passionately studying to acquire knowledge and skills on Data science and Machine learning.

PROFESSIONAL EXPERIENCE:

Confidential, Elkton, MD

Quality Engineer

• Assured Quality Systems were in full compliance with ISO regulatory agencies requirements (FDA and others)
• Process Validation to establish a controlled process, ensuring reliable product - IQ, OQ, PQ
• Performed Risk Analysis and FMEA and initiate SPC for product and process success
• Corrective and Preventative Actions (CAPA), Design Controls, Risk Management Techniques, Supplier Corrective Action Develop Control Plans
• Guided the supplier on conducting the Gage R & R studies for gages used for measuring CTQ parameters.
• Supported training of personnel in requirements of quality tools and techniques, QMS based on ISO 13485 and FDA 21 CFR 820 regulations.
• Implement SPC strategy for production sampling and testing
• Resolve to customer quality complaints.
• Conduct risk assessments for automated manufacturing equipment, computer systems and process systems as it relates to 21 CFR Part 820.
• Develop and execute Installation, Operational and Performance Qualification Protocols for Electronic Batch Management following SDLC, cGMP, FDA 21 CFR Part 600 regulations, ISO, GAMP 5 guidelines and company policies.
• Perform quality investigation and implement CAPA related to production equipment and calibration.
• Updated and modified manufacturing process validation master plans & reports
• Help in design transfer and manufacturing transfer of new products
• Development, test, and documentation to comply with IEC 60601
• Assisted in DFMEA and PFMEA analysis of different medical devices
• Execute SQL queries to validate Configuration Specification against Validation Environment.
• Worked on daily tracking and monitoring QMS for any change control requests and initiated CAPA when required.
• Perform investigation and analysis of validation outcome and implement effective solutions to solve issues, if any.
• Involved in the calibration of HPLC and GC, and checked its accuracy, detection limits, noise level, precision, reproducibility, repeatability and robustness.
• Provide technical support/troubleshooting for process and equipment issues.
• Executed the test cases using Quality Center and documented results as part of IQs, OQs and PQs.
• Performed risk management activities using Failure Mode Effect Analysis (FMEA) techniques to identify potential failure modes on pharmaceutical and medical device manufacturing equipment
• Established and maintained procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability.

Confidential, Warsaw, IN

Manufacturing Engineer

• Involved in ensuring development activities were properly documented through design control such as Risk Analyses (pFMEA), Process Validations (IQ/OQ/PQ), SOP, Protocols, ensure compliance with internal quality system in accordance with Quality System Regulations (QSR) and ISO standards.
• Involved in preparing documentation for all aspects of the computer system validation life cycle, in accordance with FDA design control and regulations, particularly 21 CFR 820.
• Initiated investigation of non-conformances within downstream Sterile and Non Sterile environment through root cause analysis (RCA), evaluation of the effectiveness of CAPA process, and initiation of action as required improving effectiveness for passivation operation.
• Hands on experience in managing Sterile Cleaning and Packaging CAPAs including use of formal problem-solving techniques, consistency in execution, completeness of content, clarity of content, and compliance with FDA 21 CFR 820.
• Conducted Internal Audits that evaluated each section of an ISO 9001 QMS with regards to Key Performance Indicators (KPI's).
• Worked on Development on Root Cause investigation tools for a CAPA on Commingles/mixed up orders and identified a remarkable process gap in the packaging process flow and implemented corrective action techniques for effective CAPA execution.
• Performed ISO 13485 Quality System review and ISO 14971 Risk Management audit review of medical devices, IAW 21 CFR 820.
• Created Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to support full testing lifecycle.
• Coordinated and reviewed actives with the team to ensure adequate documentation of the CAPA activities and actions taken in a timely manner.
• Provided CAPA and Corporate Audit metrics, trend analysis and supply reports to management that identify key overdue CAPA or Audit owner actions and rationale .
• Documenting Validation Plans, Requirement Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Experienced in developing A3 for problem solving and continuous improvement for Clean & Sterile packaging
• Performed Time Studies for Passivation and Packaging operations to increase the productivity and standardized the total run time.
• Created and Reviewed test plans, test cases, for IQ, OQ, and PQ protocols based on requirements of the applications.
• Developed and reviewed Quality/Validation Protocols, Test Method Validations, Process Validations (IQ, OQ, PQ) and Process Characterization.
• Conducted global supplier assessments to meet ISO 9001, ISO 13485, ISO 14971 and FDA 21CFR 820 requirements and ISO regulations.
• Developed and completed manufacturing requirements (Manufacturing Changes MCs, PFMEA, control plan, process flow, work instructions, and inspection plans, NCRs in Enovia) and Participated in NCMR, SCAR Process in containment, IE, root cause analysis, and implementation of permanent corrective actions.
• Worked on 3000 NCRs and investigated the root cause for deviations. Tracked, trended and management of all investigations through data analysis to reduce the non-conformance.
• Performed design verification pertaining to device QMS ISO 13485, 14971 for risk management.
• Extensive working knowledge on Blister-Tyvek packaging and Executed validations protocols for Hoods in Passivation Sterile Environment and Qualified Clean rooms
• Proficient in Risk Management, DFMEA, PFMEA, and CAPA.
• Develop and maintain company's Quality Management System (QMS) via documentation, manuals, procedures and lead the migration of ISO9001.
• Continuously redesigned the product flow by collaborating with upstream values streams to achieve desired meet the expected delivery of the product.
• Revised and developed acceptable instructions for the manufacturing cosmetic criteria Q00199 for cosmetically sensitive implants.
• Prepared detailed SOPs for IQ and PQ for validating Autoclaves and HPLC detailing more on Filter sterilization, saturated steam checks including vendor specifications.
• Logged defects into Quality Center/ Application Lifecycle Management while doing Functional Testing and followed through the process until the defects were closed.
• Developed Quality Transfer Plans by consolidating and reviewing routers, bill of materials (BOM), production set up sheets, Standard operating procedures (SOP) and technical protocols.
• Developed layout design to remodel WorkCentre’s location by value stream mapping and controlled the inventory enabling traceability and optimizing the process flow.
• Hands on experience in Quality Center, writing Requirement Traceability Matrix, SOP's, Work Instruction.

Confidential, Marquette, MI

Quality Engineer

• Managed, executed and documented the qualification and validation of equipment, processes, and manufactured components to meet the requirements
• Supported continuing engineering and new product integration quality activities. Primary activities include: pFMEA generation, developing IQ/OQ/PQ process validation protocols, and reviewing validation reports. Sustaining engineering functions to include: executing CAPA activities, supporting Supplier Quality initiatives, mitigating audit findings, supporting facility modifications, and integrating customer quality requirements with existing policies and procedures.
• Strengthened the QMS by writing and updating policies and procedures to comply with ISO regulatory standards and best practices.
• Have a thorough understanding of ISO 13485, 21 CFR Part 820 Quality System Regulations, Medical Device Directive, Canadian Medical Device Regulations, JPAL and other regulations to ensure compliance of the quality system.
• In corporate FDA guidance and external standards into functional test methods and their validation
• Involved in Test Method Validation (TMV) and V&V activities (writing IQ, OQ, and PQ).
• Conducted global supplier assessments to meet ISO 9001, ISO 13485, ISO 14971 and FDA 21CFR 820 requirements and ISO regulations.
• Experience with environmental regulations and manufacturing processes e.g. GMP, cGMP, and CAPA's and Validations.
• Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity, utilizing Minitab.
• Demonstrated application knowledge of 21 CFR 820, ISO 13485, CMDR and EEC.
• Worked on gap analysis for QMS and daily tasks for scheduling the activities related to support data migration.
• Worked with the SMEs and internal and external Reviewers to identify gaps and mitigate the risks
• Set up design and development process as per 21 CFR 820.30 & ISO13485 requirements.
• Tracked changes made to the requirements, tests and defects using Quality center.
• Responsible for verification of Design History file deliverables and review the deliverables.