SUMMARY:

• Experience as Senior Quality Engineer professional with regulations knowledge and experience in regulated industries.
• Experience in manufacturing process. Experience in method transfer and validations acceptance activities. Professional experiences as Compliance/Audit Specialist in the medical device industry; and Consent Decree Quality System Site Lead for the stability and investigation processes remediation
• Working knowledge of Quality Systems Compliance, ISO standards and ICH guidelines.
• Hands on experience in Quality Systems, Quality Assurance, Manufacturing Engineering and Risk Management including Continuous Process improvement, Test Method & Process Validations, Supplier Quality, Resource Management, Compliance Remediation, New Product Introduction, Quality Operations, Incoming/Final Inspection Labs, Design Controls and Risk Management, Design Verification & Validations, Post Market Surveillance.
• Validation protocols/reports (IQ, OQ, & PQ), Validation Master Plan (VMP), Configuration Master Plan, Test plans / scripts, requirements matrix and Validation summary reports.
• System and component Design (FMEAs). Working knowledge of FDA regulations, QSR, ISO 13485:2003, 21 CFR Part 820, ISO 14001/14971. Extensive knowledge in Problem Solving skills, Six Sigma Quality Tools, Project Management, DFMEA,/FMECA/ DFMECA/PFMEA, Gage R&R, DOE, IQ/OQ/PQ, MRB, CRB, DMAIC, Sampling Plans, Complaint Investigation, MDRs, Vigilant Reports, CAPA & Complaint Handling.
• Design/Quality Assurance proficiencies include the following subject areas such as Product Requirement Spec (Design Specifications), Quality Plan/Traceability Matrices, Risk Management File (Design FMEA, Hazard Analysis), Design History File (DHF)
• Regulatory strategies for medical product development, especially for innovative products requiring creative solutions or exemptions to comply with regulatory agency expectations. Communications with regulatory agencies
• Expertise in Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOP) as defined by medical policies to meet and International Standard Organization (ISO) regulations and Food & Drug Administration (FDA). Thorough experience in implementation of ISO (14001, 9000, 9001, 9002 & 13845).
• Process Validation proficiencies include the following subject areas such as Master Validation Plan, Risk Management File (Process FMEA), Process Validation (IQ, OQ, and PQ), Software Black Box Testing, Process Control Plan (SPC), Lean/Continuous Improvement Projects
• Statistical Data Analysis proficiencies include the following subject areas such as Process Capability Cpk, Statistical Tolerance Analysis, Hypothesis Testing - 2 sample Student T-test), Test Method Validation (MSA Gage R&R)
• Corrective and Preventive Action proficiencies include the following subject areas such as CAPA Project Expert, Failure Analysis (Fishbone Diagram, 5 Whys, Pareto Charting), Complaint Investigation, Internal and External Audit Support

PROFESSIONAL EXPERIENCE:

Confidential, Warsaw, IN

Quality Risk Engineer

• Complete review and revision of the Complaint / CAPA system to align with FDA ISO 13485 & ISO 14971, cGMP, 21 CFR 820, 210, 211, 803, 806, MDD, CE, EU requirements Review and revision of Design Control, Risk Management, MDR Reporting systems Review and revision of the Customer Complaints system to align with review and resolution Investigate, CAPA's, determine root cause, and design corrective and preventive action.
• Responsible for complaint intake, technical writing, reviewing, and documentation with compliance of the 21 CFR 803/806/810/820 , and other Food and Drug Administration regulations.
• Prepared and executed protocols and prepared final reports for IQ, OQ and/or PQ of equipment’s such as Incubators, Centrifuges, Freezers, Autoclaves, Vessels etc.
• Conducted Validation and Qualification reviews, High Level Risk Assessment for Class II and Class III Medical device and processes.
• Ensured compliance with internal and external quality and regulatory requirements during product development cycle and commercialization of Class II and Class III new products.
• Collaborated closely with R&D organization and other functions as quality member on the product development team. Collaborated with R&D in writing and reviewing product validation and verification protocols and reports.
• Prepared detailed SOPs for IQ and PQ for validating Autoclaves and HPLC detailing more on Filter sterilization, saturated steam checks including vendor specifications.
• Earned Value Tracking, and formal project risk management.
• Changes established project predictability, goal attainment, and departmental consistency across the portfolio. Was responsible for Risk Management, documentation, and assurance that Design and Manufacturing process changes.
• Reviewed Validation Master Plan (VMP) and Validation Protocols (IQs, OQs and PQs) in detail.
• Assists in timely closure of complaint files and adverse events to ensure pertinent information is within file prior to closing.
• Developed SOPs and URS, IQs, OQs, PQs for validation of Computer systems specifically for the Electronic Records and Signatures.
• Initiate and complete compliance reports for adverse events and or reportable malfunctions.
• Interface with various internal resources such as Manufacturing, Engineers, Product Development and the Legal Department to assist with obtaining completed information regarding product complaint.
• Peer review to ensure complaint closure and quality is in compliance with the company Standard Operation Procedures.
• Supported CAPA maintenance activities for existing product lines, adverse reporting and data collections.
• Reviewed information from multiple databases and systems -ETQ, MedDRA Coding.

Confidential, Ann Arbor, MI

Quality Risk Engineer

• Carried out all the Quality/Manufacturing Engineering activities for Sustaining Engineering, Managing Change Control, Product development and product maintenance such as Quality Plans, Metrology and Reliability Testing activities FMEA's, Voice of Customer (VOC), Customer Complaints and Root Cause Investigations ), Quality Management Support Activities (QMS) as a Lead Auditor, Post Market Surveillance Activities Review (PMS), Control Plans, Qualifications, Process Validations, Measurement System Analysis (MSA's), gage R&R's along with Design Verifications.
• 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.
• Review and support risk management to ensure high level of compliance to FDA QSR 21 CFR 820, ISO 13485 and ISO 14971and European standard in all assigned areas.
• Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA) and drafting Remediation Plans for the project management approval after the GAP Analysis.
• Review/Write and execute IQ/OQ/PQ Protocols for computer systems software validation to ensure that the system conforms to user specifications and business intended use and functions as expected.
• Developed and executed documents IQ/OQ/PQ temperature monitoring studies.
• Maintain FDA Quality System Regulation 21 CFR 820 (Food & Drug Administration) and ISO 13485 (International Organization for Standardization) regulatory requirements.
• Maintained Regulatory compliance with ISO 13845, ISO 14971 Risk Management, FDA QSR and CMDR.
• Lead CAPA investigations and related corrective and preventive actions for Packaging
• Review and evaluate PMA, 510K, Pre-IDE, IDE, and CE Mark submission dossiers to meet with global needs.
• Provide guidance and interpretation of global regulatory and quality requirements to ensure efficient use of product resources.
• Prioritized, developed, and updated equipment IQ/OQ/PQ validation test documents for CNC fabrication equipment and final assembly processes to validate production processes for medical beds using ISO 13485/Part 820/ISO 14971 as guidance.
• Managed the completion and approval of required tests to meet regulatory requirements to introduce new packaging components.
• Developing and updating Risk assessment for new products.
• Oversee responses to government regulatory and quality queries and correspondence.
• Partner on planning, execution and reporting of human clinical studies with a special emphasis on ensuring compliance with Global Good Clinical Practices development, statistical data analysis, and the development of sample plans during NCR, CAPA and validations.
• Developed the in-process testing requirement (Sample size) based on the Process Capability documented during OQ/PQ using Minitab.
• Performed product risk analysis and updated risk management documents (Hazard Analysis, Use FMEA, DFMEA) for both Medical Electrical Equipment and Medical Electrical Systems.

Confidential - Indianápolis, IN

Quality Engineer

• Proven ability to assist and create novel solutions to technical problems within product/packaging development from idea inspection to product development & launch R&D, Design, Test Method Development (V&V, R&R), Design Verification & Validation, Design Transfer, Field Assessment, etc.
• Conduct investigations of devices and information supplied through the complaint management process, as well as initiation of actions identified to improve device quality, reliability and customer experience, including visual and photographic assessment of product condition, functional testing or the disassembly of returned device(s) in order to isolate the source of failure and make a definitive root cause analysis.
• Plan and ensure/comply internal design control policy, regulatory, and external standards (FDA Quality System Regulation, ISO 13485, and EU Medical Device Directive, ISO 14971, IEC 60601) implementation at each stage of product development life cycle.
• Worked with product development and vendors to change processes/products for manufacturability.
• Perform risk management activities (Hazard Analysis, Fault Tree Analysis, Use FMEA and Design FMEA) and auditing the DHF
• Maintained strong collaborative partnership with cross-functional team members to complete complaint investigation and other technical reports. Conducted reviews of complaint trending for CAPA eligibility, Research & Development support and Post Market Surveillance Reviews.
• Maintained current knowledge of complaint handling regulations, guidelines, and standards and applied the appropriate implementation strategies. Gave direction and support to Process Validation Remediation (PVR) team.
• Handle complaints with the understanding of products at site and various failure modes associated with these products; with and without products returned and evaluate and document the root cause of the failure and effectively communicate the results of an investigative analysis through written reports documented under the elements of the Glob-al Quality System. Review of design and development documentation for functional, manufacturing, V&V, and quality cha-racteristics.
• Seasoned audit facing SME for quality and regulatory process during FDA, TUV, DEKRA, BSI and other regulatory agency inspections.
• Participates in risk analysis for all reported complaints, Conducts and controls shipping logistics of sending and receiving parts to and from the supplier respectively, and also to internal sites for further evaluations
• Using SPC, DOE, ANOVA, Six Sigma, Quality Control methodologies, gauge R&R, and Advanced Statistical methods in product design, test method development, test sample selection, and test data analysis.
• Responsible for hands on quality assurance efforts, maintaining regulatory compliance, and CAPAs.
• Utilized advanced statistical analysis techniques to determine product acceptance against product specification and user need requirements.
• Served as design assurance core team member to facilitate product transfer activities to new manufacturing facility.
• Participated in design reviews, design transfers, and in all aspects of the Design Control and risk management processes.