Engineer Quality Assurance
Resume:
MARK TAYLOR
acz7rg@r.postjobfree.com
Summary:
7+ years of Professional experience in Validation/ Test Engineer/FDA Compliance Specialist experience in Medical devices and Manufacturing industry with emphasis on Instrument/Equipment Validation, Cleaning & Process Validation,Project Management & Software Quality Assurance/Manufacturing. He has sound Knowledge and experience in working with GxP suites: GLP, GMP, GCP, GAMP 4 and GAMP5. Has excellent understanding of quality concepts, audits & standards, ISO 9001, Six Sigma, CAPA, SPC, DHF, and DOE.
Synopsis:
•Extensive experience in FDA 21 CFR Part 11, CFR 211/210 validation, performing Gap analysis, Remediation Plan, SOPs, Validation Protocols, Technical Writing, Quality Assurance, Automated Test Tools and Test cases and Corrective and Preventive Actions (CAPA)
•Experienced with transfer new product to manufacturing and Process improvement, Equipment Validation and Qualification (IQ/IQ/PQ). Supplier Corrective Action Report (SCAR) and Scorecard experience while working with the Material Review Board (MRB).
•Performed test method validations (Gage R&R studies - Minitab). Statistical Data Analysis Experience using Minitab. Strong knowledge about Medical device regulations like FDA: 21 CFR Part 11, 21 CFR Part 58, 21 CFR Part 210, 21 CFR Part 211 and 21 CFR Part 820.
•Expert background of Software Development Life Cycle (SDLC) and Validation Life Cycle (VLC). Familiar with Waterfall, Agile, and V-model. Expertise in writing Installation Qualification (IQ) protocol, Operational Qualification (OQ) protocol, Performance Qualification (PQ) protocol and Standard Operating Procedures (SOPs).
•Extensive experience in developing Test Plan, Test Cases and Test Summary Report.
•Expertise in using Documentum, Sharepoint, TrackWise, Laboratory Information Management System (LIMS), HP Quality Center, Adverse Event Reporting System (AERS).
•In-depth experience in handling High Performance Liquid Chromatography, Gas Chromatography, Autoclaves, Incubators, Sterilizers, Ovens, Cold rooms and Clean areas. Proficient in performing Gap Analysis, reviewing and performing Corrective and Preventive Action (CAPA), suggesting Remediation Plan to mitigate non-compliance, data migration and performing periodic reviews.
•Expertise in Key Value offered such as DOE, NCR, QIR and CAPA, Value Stream Mapping, Process Validation,Root Cause Analysis, Continuous Improvement (CI), IQ, OQ, PQ, ISO 13485, 14971, Gap Analysis/Remediation, FAI, 21 CFR 820, 11, Supplier Quality Assessments, PPAP,cGMP, Fishbone, DHF, Minitab, TMV, SPC, FMEA, AutoCAD/ Soildworks Familiar with ISO 13485, 14971, 62304, CFR 820 and all Process Validation for Medical Devices -IQ, OQ and PQ.
Work Experience:
Boston Scientific, Spencer, IN, June 2015 - Current
Sr.Validation Engineer
Key Focus: Create Test Method (TM), Test Method Validation (TMV), Test Method Validation Report (TMVR), IQ, OP, PQ protocol documentation for Boston Scientific's medical devices products to meet Corporate and FDA regulatory compliance using MS Word, Excel.
•Create Process Flow Diagrams (PFDs) to illustrate the manufacturing process of medical devices using Visio.
•Loaded IQ, OP, PQ, TMV documents into PDM (Product Data Management) system, (a controlled document/data management system) for review and approval signatures.
•Provide training documentation using MS PowerPoint, Word and Visio.
•Performed Design of Experiments (DOE). Determined manufacturing process limit requirements and processing parameters to qualify/validate processes. Documented process data to verify repeatability, reproducibility and specifically, requirements based on intended use.
•Continued on qualification/validation activities to 21 CFR, Parts 11 and 820, along with QMS ISO-13485.
•Responsible for authoring, performing and/or approving qualification and validation documentation such as System Design Requirement Specifications (SDRS), Change Control, Document Change Notice (DCN), Non Conformance Reporting (NCR), GAP Analyses, CAPA, Process Failure Mode and Effect Analyses (PFMEA's), Engineering Studies (ES),Process Verification and Qualification, Design History Records (DHR), Protocols, SOPs and Test Methods.
•Support technology transfer activities, process/ software characterization studies and gauge R&R studies within the Manufacturing Process.
•Responsible for supporting manufacturing for development process activities such as process and equipment validation and qualification (IQ/OQ/PQ).
St Jude Medical, Minneapolis, MN, Sept 2013 - May 2015
Validation Engineer
Key Focus: Served as a Validation/Quality representative on a cross-functional new product development team. Responsibilities included creating, identifying and validating all risk based process validation activities.
•Created documents such as PFMEA, MVP, TMV, IQ, OQ, PQ etc.
•Created or reviewed PFMEA, IQ/OQ/PQ/PPQ protocols and reports, analyzed test results, communicated findings and got approvals across all functional teams involved
•Equipment cleaning procedure for the process validated.
•Reviewed and approved Equipment/Process documentation including: Process FMEAs, Engineering Studies, Installation Qualifications, Operational Qualifications, and Performance Qualifications.
•Executed statistical studies of data(e.g., distribution analysis, crossed & nested R&Rs)
• Support Operations, Engineering, Program Management and other functional groups by leading close loop root cause analysis (RCA), Corrective Action & Preventive Action (CAPA), Gage R & R) to assure internal and supplier manufacturing process effectiveness.
Baxter, IL, May 2011 - June 2013
Validation Test Engineer
Key Focus: Managed and worked with suppliers on quality issues for computer and laboratory systems such as pH meters, chromatographs, spectrophotometers and HPLC.
•Reviewed Validation Protocol (IQs, OQs, and PQs) and make sure they are as per company guideline.
•Developed statistical process improvement plans and successfully executed them utilizing some of the six sigma tools.
•Processed FMEAs, corrective actions and customer quality concerns.
•Implemented business plans and supplier agreements.
•Implemented validation strategy for process control and automation systems to combine Equipment, Process and Computer validation per Companies standards.
•Involved in drafting compliance report about the existing status of cGLP, cGMP and cGCP
Par Pharmaceuticals - Huntsville, AL October 2010 - April 2011
Quality/ Validation Engineer
Par Pharmaceutical, develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life.
•Reviewed and approved IQ, OQ, UAT, VSR, for the completeness, Accuracy and in compliance with the company’s SOP
•Trained other personnel on Good documentation Practices and how to execute test scripts as per company’s SOP
•Reviewed the pre and post executed OQ protocols for completeness and accuracy
•Develop FAT, IQ, OQ, PQ Summary Reports, SOPs, Engineering Change Requests, etc.
•Qualification and validation of Packaging Lines including Serialization Systems.
•Verification, clarification and sign-off of the functional requirements/functional specification
•Developed fully documented test and validation plans, preparation and execution of IQ, OQ, documentation of Test and Validation reports, Test Defects, and Traceability Matrix
•Document strategy for maintaining the Validated State
Medical Product Laboratories Inc, Philadelphia, PA, Aug 2009 – Sep 2010
Validation/ Quality Manufacturing Analyst
Key Focus:Provided guidance and support to Production, Manufacturing, and Equipment Engineering subject matter experts (SMEs) for the development, implementation, and execution of validation lifecycle activities.
•Designed procedures and test methods which comply with business, Regulatory, FDA, and industry best-practice guidelines: FDA 21 CFR Part 820 and Part 11; ISO 14971 and 13485; cGMP; GAMP4.
•Developed validation documentation (Requirements; Design Specifications; Risk Assessment; IQ, OQ, PQ; RTM; and Reports) for manufacturing processes, systems, and equipment.
•Supervised and participated in the implementation of quality assurance procedures and test processes.
•Identified and assessed impact of Change Control activities for validated equipment, software, and systems.
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