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Validation Lead Resume

5.00 Rating

Dayton, OH

SUMMARY:

  • Over 35 years of multidisciplinary contributions and experience medical devices class I, II & III devices, and in vitro diagnostics, pharmaceutical and aerospace manufacturing industries.
  • Expertise and implementation of ISO 13485, 21 CFR 820 and ISO 14971 implementation
  • Expert in implantation of Quality System remediation in varies medical devices manufacturing companies
  • Worked with R&D for new product development and quality assurance and process requirements for new products. PMA & 510(k) submission.
  • Developed and executed (SDLC) Software Development Life Cycle plans for tools and test box software
  • Product transfer and contract manufacturing facilities audits.
  • Parts and products cleaning methodology
  • Expert on remediation process validation, Quality systems improvement Plan.
  • Developed SOPs and Work instructions for Medical Device Production Part Approval Process (PPAP)system.
  • Developed Computer Software Validation (CSV) as part of manufacturing process validations.
  • Expert in GD&T trained operators.
  • Developed Plans for Transfer products and technology from one facility to another facility.
  • Developed SOPs and procedures for non - conforming materials and rote cause analysis.
  • Developed process for Unique Device Identification (UDI) process.
  • Strong diversified background in quality engineering, process engineering & reliability engineering with an emphasis in medical devices manufacturing industry.
  • Expertise in quality engineering, quality assurance, design of experiment (DOE), process control, JIT, lean manufacturing, new product deliverables to production, quality control and software quality assurance, reliability engineering testing, Risk Management, medical device reporting (MDR) and ABC/ABM system.
  • Expertise in CAPA system procedures and implementation and supplier corrective action system (SCAR), risk management and problem solving techniques and the implementation of solutions.
  • Expertise in cleaning/ packaging/sterilization/ process validation IQ, OQ, PQ, PPQ, TMV, ATMV,VTMV, DOE, & pFMEAs (ISO 14971) developments, design verification & validation, prepare, executed, and analyzes data for IQ, OQ, PQ, PPQ, TMV, ATMV, DOE & pFMEAs protocol and reports. Performed physical test methods, test methods development, validation test samples development, and training of operators and generate reports with validation data analysis and trained engineers on process validation activities.
  • Computer Software Validation (CSV) as part of manufacturing process validations.
  • Aseptic Processes Validation (i.e. media simulation activities), bulk sterilization, and filter validation activities as well as the generation of project plans.
  • Knowledge and experience in bioburden, biocompatibility, sterilization for medical devices, parts, implant kits and packaging.
  • Expertise in supplier management & audits, technical support, audits and implementations, maintaining supplier corrective action system (SCAR).
  • Expertise in 21 CFR 820 - Quality System Regulation, 21 CFR Parts 210/211, cGMP in manufacturing, 21
  • CFR 803 medical device reporting (MDR) and medical device vigilance Reports (MDV).
  • ISO 2001:2000, ISO 13485:2003 Medical Devices- Quality management systems-Requirements for regulatory purposes also ISO 14971:2007, 60812, 60601, 10555-4, 14299, 25539-2 requirements and GHTF Process validation and Software Validation guidance.
  • Expertise in writing SOP, WI, MP and OP’s and developing R&R, ANOVA, process capability studies, and normality assessment during the test method validation development.
  • Expertise in gap analysis mock audits, process audits, products audits, internal quality system audits, supplier audits and compliance audits.
  • Knowledgeable in cPDM/PDM, Agile, Minitab, WinSMITH Weibull software, Smartsolve software, netregulis for CAPA software, Windows and Excel. Possess strong leadership and communication skills, high attention to detail, dutiful respect for compliance in all regulated environments, as well as managerial skills including hiring, termination, scheduling, training, and other administrate tasks.
  • Expertise in Implementation of JIT and Lean Manufacturing as process engineer.
  • Hands on experience & knowledge in implementation of Six Sigma Techniques.

WORK EXPERIENCE:

Confidential, Dayton, OH

Validation Lead

Responsibilities:

  • Managed Validation Remediation Project as per 21 CFR Part 820.75
  • Developed Validation Master Plan and validation plans and reviewed existing MVPs
  • Developed IQ, OQPQ & TMVs plans and reports using Measurement System Analysis (MSA.)
  • Developed D,PFMEAs as per ISO 14971 with process mapping/Process flow requirements
  • Developed cleaning validation plans for new products and developed production part approval process (PPAP).
  • Developed SOPs and procedures for implementations of UDI for class II & III devices.
  • Developed procedures for monitoring validated manufacturing process using statistical techniques.
  • Assessed recently opened CAPAs to determine their root causes being properly identified and effectiveness of resolution are properly implemented.
  • Managed contractors & trained on valuations/TMVs, SPC and QMS.

Confidential, Bedford, MA

Product Transfer, Quality/Validation Manager

Responsibilities:

  • Managed products move to contract manufacturing facility in Mexico
  • Developed, reviewed and approved site master validation, product validation plan, product quality plan, process mapping/process requirements and D, P FEMAs as per ISO 14971.
  • Developed SOP for risk based sampling plans.
  • Manage cassette Assay validation for IVD project
  • Developed Site MVP/MVPs and reviewed existing MVPS
  • Manage, interact and audited before and after transfer contract manufacturing site.
  • Assessed internal/external audits and CAPAs for the containments and resolutions
  • Develop validation IQ, OQPQ, TMVs plans & reports, process mapping and reports for move.
  • Created transfer plans for FDA notification with RA/QA.
  • Developed Computer Software Validation (CSV) as part of manufacturing process validations.
  • Performed audits for Confidential on contract manufacturing facilities.
  • Developed SOPs and procedures for implementations of UDI for class II & III devices.
  • Developed procedures for monitoring validated manufacturing process using statistical techniques.
  • Developed and implemented plan to prevent non - conforming product.
  • Performed audits per ISO 13485 and 21 CFR 820 (QSR).
  • Managed contractors & trained on valuations/TMVs,SPC and QMS.

Confidential, Warsaw, Indiana

Process Validation/Remediation, Manager

Responsibilities:

  • Managing remediation, performing and implementing process validation Plans, protocols and reports for orthopedic devices. Expert in cleaning validation for orthopedic devices
  • Expert on remediation process validation IQ, OQPQ, COPA, Quality Improvement Plan and Auditing and gap analysis.
  • Developed and executed software/process validation plans & reports.
  • Developed MVPs for new products and reviewed existing MVPs for remediation
  • Hands-on management style providing leadership and strong remediation project skills.
  • Performed audits for Zimmer on contract manufacturing facilities.
  • Developed SOPs and procedures for implementations of UDI for class II & III devices.
  • Developed procedures for monitoring validated manufacturing process using statistical techniques.
  • Developed Computer Software Validation (CSV) as part of manufacturing process validations.
  • Developed procedures for Supplier Quality System
  • Performed internal audits as per 21 CFR 820/ISO 13485 (QSR).
  • Developed and implemented plan to prevent non-conforming product.
  • Managed contractors & trained on valuations/TMVs, SPC and QMS.

Confidential, Atlanta, GA

Design & Development, Quality Manager

Responsibilities:

  • Created new and updated existing SOPs and procedures for Design and Development activities for manufacturing of contact lenses as per 21 CFR part 820.30 and ISO 13485
  • Set up design and development process as per 21 CFR Part 820.30 & ISO13485 requirements.
  • Created Verification and Validation SOP and Templates for remediation.
  • Developed D, P FMEAs as per ISO 14971 with process mapping/Process flow requirements
  • Hands-on management style providing leadership and strong remediation project skills.

Confidential, Irvine, CA

Lead Quality/Validation Manager

Responsibilities:

  • Remediation Project Lead validation engineer for Atrial Fibrillation product lines at Irvine, CA facility.
  • Developed Site Master Validation Plan
  • Developed SOPs and procedures for remediation process validation
  • Performed assessments on previously validated process validation/MVPs documents.
  • Developed SOPs and procedures for implementations of UDI for class II & III devices
  • Conducted Hands on validation training for quality engineers, R&D engineers, manufacturing engineers and advanced manufacturing engineers.
  • Performed and created Process Validation/software validation Plans, policies, Process Maps, Process Requirements, pFMEA and reports for IQ, OQ, PQ and TMVs.
  • Performed audits as per 13485.
  • Developed MVPs for remediation of equipment and instruments for Atrial Fibrillation devices.
  • Planed and Performed validation on transferred equipment to another country.
  • Developed procedure for no-conforming materials and rote cause analysis.
  • Developed Computer Software Validation (CSV) as part of manufacturing process validations.
  • Validated Labeling Process.
  • Managed contractors & trained on valuations/TMVs, SPC and QMS.

Confidential, Sylmar, CA

Lead Quality/Validation Engineer

Responsibilities:

  • Performing and creating Process Validation Plans, Process Maps, Process Requirements, pFMEA and reports for IQ, OQ, PQ and MVPs for relocation equipment and instruments in the new manufacturing facility for Cochlear Implants as per ISO 13485, ISO 14971 and 21 CFR 820 requirements.

Confidential, Valencia, CA

Lead Quality/Validation Engineer

Responsibilities:

  • Performed and created Process Validation Plans and reports for IQ, OQ PQ and TMVs for relocated equipment and instruments in the new clean room facility for Leads, Paddle Leads and Spinal Cord Stimulator (SCS) Implants as per ISO 13485, ISO 14971 and 21 CFR 820.
  • Export on remediation process validation.
  • Managed contractors

Confidential, Kalamazoo, MI

Sr. Quality Engineer

Responsibilities:

  • Performed assessments and gap analyses on medical device reporting (MDR) remediated reports and submitting into Medwatch system.
  • Investigated and filed new MDR into Medwatch.
  • Performed CAPA gap assessments on CAPA files for Pain Pumps for remediation.
  • Managed contractors for the project

Confidential, Seattle, WA

Sr. Quality Engineer

Responsibilities:

  • Performed assessments and gap analyses on previously validated process validation documents from the Physio Control printed circuit board assembly’s vendors for remediation for printed circuit boards for Heart Defibulators for remediation.
  • Developed validation plan, OQ, PQ plans with MSA requirements.

Confidential, Miami Lakes, Florida

Sr. Quality/Validation Engineer

Responsibilities:

  • Worked with R&D department for new product development to generate andperformed test method validation plans/assessment and reports on new stents.
  • Developed pFMEAs for the new products with process mapping and risk based approach ISO 14971.
  • Generated & performed TMV protocols and reports for mechanical properties of stent material, stent integrity, stent radial stiffness, stent radial strength, hydrophilic lubricity coating.
  • Reviewed initial tensile strength reliability data and generated reliability reports.
  • Generated & Performed test methods, test methods development, validation test samples development, trained operators and generated reports with validation data analysis.

Confidential, Miami Lakes, Florida

Senior Quality/Validation Engineer

Responsibilities:

  • Worked with R&D department for new products development and performed gap analysis for Risk Management system as per 14971:2007 and generated SOP’s.
  • Updated Risk management process and hazard analysis SOP’s as per 14971:2007 for risk management system.
  • Developed SOP for medical device reporting system (MDR) and medical device vigilance report (MDV) for Heart Pump. PMA & 510(k) and CE marking submission.
  • Created a master move validation plan for the facility move from Miramar, FL to Miami Lakes, FL facility.
  • Decommissioned equipment and test equipment at Miramar facility and commissioned equipment and test equipment at Miami Lakes facility.
  • Performed validation on packaging and leaser welding equipment at Miami Lakes facility. Developed equivalency report before and after facility move for FDA for Heart Pump.
  • Generated and executed process/software validation for laser welding processes fir six assemblies. Responsible for writing and executing of IQ, OQ/PQ, VTMV, ATMV, ETR and DOE for laser welding process. Performed reliability testing on the leaser welded parts for Heart Pump.
  • Developed and executed IQ, OQ & PQ for the SS300 and SS400 series and titanium parts cleaning validation. Used aqueous solution, vapor degreaser and passivation cleaning methods.
  • Developed and executed IQ, OQ & PQ for the SS300 and SS400 series and titanium parts cleaning validation. Used aqueous solution, vapor degreaser and passivation cleaning methods. Developed SOP for bio-burden levels testing.
  • Developed packaging biocompatibility plan for implant coring tool kit for Heart Pump.
  • Developed SOP for bio-burden levels testing. Developed packaging biocompatibility plan for implant coring tool kit for Heart Pump.
  • Performed clean room validation, ovens, packing machine, refrigeration, electrical, compressed air and DI water system.
  • Submitted SOPs, FMEAs, validation protocols and reports, ECN documentation control through Agile.
  • Performed test methods, test methods development techniques, validation test samples development, trained operators and generated reports with data analysis.

Confidential, Dallas, Texas

Senior Quality Engineer

Responsibilities:

  • Responsible for performing assessment on previously performed process validation Documents for remediation.
  • Developed and performed IQ, OQ and PQ for revalidation activities for DI water systems.

Confidential, Miami, Florida

Senior Quality Engineer

Responsibilities:

  • Project Horizon Process Validation Remediation (PVR), conducted compliance audits and issued audit reports on MVP/MVR protocol/reports, IQ, OQ, PQ, PPQ TMV, pFMEA on Remediate Process Validation documents as per ISO 13485, ISO 14971 and 21 CFR 820 requirements.
  • Performed R&R, ANOVA, MSA, process capability studies, and normality assessment during the process validation development and implementation.
  • Perform third party audits
  • Audited validation documents
  • Export on remediation process validation

Confidential, Dorado, Puerto Rico

Senior Quality Engineer

Responsibilities:

  • Responsible for generating validation (IQ, OQ, PQ, and PPQ) protocols executing validation protocols, and writing summary reports. QA audits performed on validated products.
  • Performed software for test boxes clean room validation, ovens, packing machine, refrigeration, electrical, compressed air, and DI water systems for remediation.
  • Supported the qualification of aseptic processes (i.e. media simulation activities), bulk sterilization, and filter validation activities as well as the generated project plans.
  • Managed major job functions included: generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, manage project time lines

Confidential

Senior Process/Quality Engineer

Responsibilities:

  • Trained cotton industry management and employees on ISO 9002 and SPC.
  • Setup quality systems, JIT, mechanical measurement techniques.
  • Implemented quality documentation systems.

Confidential, Miami, Florida

Senior Process/Quality Engineer

Responsibilities:

  • Responsible for quality activities, auditing, implementing FAA rules and regulations for aircraft TSO seating and FFA RTCA/DO-254 compliance.
  • Implemented and audited ISO requirements, process control, process validation & qualification prior to Lean Manufacturing Implementation.
  • Conducted first article inspection and implemented vendor qualification procedures.
  • Generated and executed process validation protocols for passivation cleaning for CNC fabricated aircraft aluminum SS400 series parts.
  • Implemented and performed conformity and quality inspection at the customer site on finished TSO products.
  • Implemented Lean Manufacturing.
  • Performed and witnessed testing and conformity inspection as a DOR for 6G seats and compliance certification requirements.
  • Performed validation & verification, process assurance, configuration management and certification liaison

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