Senior Quality Assurance Associate

• Sep 2021 - Present

Senior Quality Assurance Associate

• Oct 2022 - Feb 2023

Special assignment working on a continuous improvement project. Special assignment working on a continuous improvement project.

Senior Quality Engineer

• Aug 2019 - Sep 2021

* Support site Quality Engineering department, with on-going local and inter-company projects, Change Controls, NC's, CAPA´s etc. * Support site Quality Compliance department, with on-going audit program as internal auditor ISO 13485:2016. * Support site Quality Operations Laboratory department, with on-going validations. * Support site Quality Engineering department, with on-going local and inter-company projects, Change Controls, NC's, CAPA´s etc. * Support site Quality Compliance department, with on-going audit program as internal auditor ISO 13485:2016. * Support site Quality Operations Laboratory department, with on-going validations.

Quality Assurance Specialist

• Jul 2016 - Jul 2019

Primary core tasks: * Support quality improvement projects throughout the life cycle of DORC products * Support Operations, New Product Development, Engineering, Lean department with company related projects as a Quality representative (on Risk Management, Quality Operations, Engineering, Compliance, Quality Systems, Control and Microbiological expertise) * Support Change Control Process related to product, process, raw materials, supplier changes * Support site validation for manufacturing processes/equipment/test methods as sme * Support on NC’s, CAPA’s and OOS * Support on Biocomp, Toxicologic studies , Clinical Evaluations * Lead Auditor ISO 13485:2016 * Support on MDSAP, new MDR/ and ISO 13485:2016 readiness and implementation * Support on Product Risk and Escalation/Health Hazard Evaluation/Vigilance process Sterility Assurance SME: * Microbiology SME (Sterilization, Packaging, Bioburden, Endotoxine, Cleanroom, and Environmental testing) * Annual re-qualification activities for Cleanroom and 100% Ethylene Oxide sterilization processes * Automatic cleaning/reprocessing, Steam sterilization (re-validations, worst case determination, changes) * Lead deviation investigation and resolution for sterilization process at contract sterilizers (Sterigenics/Steris) * Responsible for parametric/BI release of routine sterilization process * Established test method validation policy for microbiological methods Show less

Senior Quality Engineer

• Dec 2014 - Jul 2016

Primary Core tasks:•Support and Co-Lead site/inter-company related projects as a Quality representative•Support and Co-Lead production/laboratory/facilities Failure Investigations for NC´s, CAPA´s and OOS•Responsible for bounding determination/rationale, Product Risk Assessment•Establish samplings plans utilizing statistical tools and techniques•Lead quality improvements projects throughout the life cycle of Mentor products•Lead and Sustain Site Validation Master Plan for manufacturing processes/equipment, laboratory equipment, Test Methods, Facilities, Sterilization, computerized systems etc •Lead and Sustain Control Plans and Critical Control Flags•Responsible for maintaining the pFMEA’s updated and ensure correctnessSecondary Core tasks:•Audit SME for several Quality and Lab Engineering related subjects•Review and approve NCR closure •Review and approve Change Management Requests •Backup and Act in absence of Quality Operations ManagerSterilization and Microbiology subjects:•Contribute for maintaining the Bioburden, Endotoxin and Environmental Monitoring Program with respect to regulation/ISO changes•Review and approve NCR closures related to EM, HVAC, Pressure differentials and other related Facility or contamination•Sterilization (Dry Heat) and Microbiological SME •Provide microbiological training on GxP subjects to QO Lab Technicians •Guide lab and operations in order to execute proper Environmental Monitoring in case a major renovation, multistep renovation or new construction of a CME area.•Support Micro Lab in the yearly NPRT test•Endotoxin, Bioburden and Biological Indicator test method validation SME.•Provide guidance during incoming inspection of new batch Biological Indicators strips (D-value, z-value determination)•Contribute for maintaining the cleaning program•Backup and Act in absence of Staff Sterilization and Microbiology Engineer Show less

Quality Operations Laboratory Engineer

• Jun 2012 - Nov 2014

Core Tasks:=>Statistical Analysis=>Working on my Green-Belt project, including budget management=>Evaluates compliance with applicable standards ISO 13485, 21CFR11,ASTM F703=>SME during regulatory, notified body audits/inspections.=>Defining, developing and improving laboratory procedures including test method validations=>Project leader for laboratory projects=>Coordination of non-routine laboratory testing activities including validation testing=>Work on audits observations/NCR/CAPA files from origination to full cycle completion and final approval=> Maintain Test database Labware LIMS and program activities=> Plan, Organize, write, review, execute validation protocols.=> Execute cycle development and performance qualification on a wide variety of equipment.=> Responsible for Biological Indicators testing, (D-value, z-value determination), Sterility Testing=> Writing procedures to cover current demands on quality approach - Test Method Validations of the Bioburden of medical devices, according to i.e ISO, EP and USP=>Responsible for Computer System Validation (GAMP 5) of multiple laboratory equipment - Qualification activities (IQ, OQ, PQ, CSV,TMV) of several lab equipment, i.e. Instron Material Tester, Viscometer, Rheometer, FT-IR, Texture analyser etc - according to International Standards ISO/EN, 21CFR11, ASTM, EP and USP =>Participate in evaluating in Environmental Monitoring of Cleanrooms and - Yearly Alert/action Limit review=> Participate in evaluating the current quality systems and implement improvements to comply with the current EU/FDA standards=> Troubleshooting Microbiology Lab (environmental monitoring, bioburden, endotoxins (LAL tests) and sterility testing).=> Troubleshooting Analytical Lab (Physical property testing of finished devices, intermediates and Incoming material testing)=> Trending for NCR and OOS/OOT, using LIMS, Minitab=> Support tasks for the Capa Review Board (i.e. EM trend, In coming, In process analysis) Show less

Scientific Researcher

• Jan 2012 - Jun 2012

Department of neuropathology working on Multiple Sclerosis Department of neuropathology working on Multiple Sclerosis

Scientific Researcher

• Jan 2009 - Jan 2012

Department of Immunobiology 2009-2011 Animal Science Department 2011- January 2012 Worked on contract based research in autoimmune diseases; Animal models, Parkinson, Transplantation, Experimental Autoimmune Encephalomyelitis, Myasthenia Gravis, using a variety of techniques (FACS, ELISA, HPLC, RT-PCR, Cel-Cultures, Elispot and others) Department of Immunobiology 2009-2011 Animal Science Department 2011- January 2012 Worked on contract based research in autoimmune diseases; Animal models, Parkinson, Transplantation, Experimental Autoimmune Encephalomyelitis, Myasthenia Gravis, using a variety of techniques (FACS, ELISA, HPLC, RT-PCR, Cel-Cultures, Elispot and others)

Research Associate

• Aug 2008 - Jan 2009

Department "Specials", Chemical Analyses using GC-MS, HPLC and TOF under GLP conditions and Validation/implementation of new Test Methods Carrying out all the preparatory and analytical work, periodic validation, Interpreting and reporting chemical analysis, troubleshooting, handling customers complaints (in relation of the reported results OOS) Department "Specials", Chemical Analyses using GC-MS, HPLC and TOF under GLP conditions and Validation/implementation of new Test Methods Carrying out all the preparatory and analytical work, periodic validation, Interpreting and reporting chemical analysis, troubleshooting, handling customers complaints (in relation of the reported results OOS)

Developing Food Safety Program - Catering/Restaurants

• Aug 2003 - Aug 2008

Implementing Food Safety Program using HACCP principles and according to ISO 22000 =>Identifying food handling activities, hazards, and performing Microbial Analyses using Classic Microbiology methods in corporation with/and using University facilities and services. =>Implement Corrections and Preventive/Corrective actions =>Staff training =>Submit the program to local government Implementing Food Safety Program using HACCP principles and according to ISO 22000 =>Identifying food handling activities, hazards, and performing Microbial Analyses using Classic Microbiology methods in corporation with/and using University facilities and services. =>Implement Corrections and Preventive/Corrective actions =>Staff training =>Submit the program to local government

Elite cyclist/mountainbiker

• Jan 2001 - Aug 2008

Elite cyclist, Team Nutrition Specialist, Mental training and coaching athletes including youth team coach. Elite cyclist, Team Nutrition Specialist, Mental training and coaching athletes including youth team coach.

Milupa Produção - Fabrico de Produtos Alimentares, S.A. (NUMICO)

• Mar 2003 - Oct 2003

Internship Food Safety (Microbiology, Sanitation, Cleaning efficacy/validation, GMP and HACCP) Microbiological control of in coming products (raw materials), in processing products and finished products (Baby food). Microbiological control Environmental Monitoring of Controlled Manufacturing Environment, MairT, Particles measurement, Contact plate, water analysis. Internship Food Safety (Microbiology, Sanitation, Cleaning efficacy/validation, GMP and HACCP) Microbiological control of in coming products (raw materials), in processing products and finished products (Baby food). Microbiological control Environmental Monitoring of Controlled Manufacturing Environment, MairT, Particles measurement, Contact plate, water analysis.

Tactical Aircraft Maintenance Officer

• 1999 - 2002

Officer Managing 711 Squadron, AVIOCAR C-212-100 and PUMA Aérospatiale SA 330 Supervising Military Personnel: - supervising the military and civilian technicians/repairing staff. - checking whether all the safety regulations are being followed during the maintenance process Scheduling Maintenance and Repair - scheduling the maintenance and servicing of aircraft,coordinating the maintenance plans and schedules to meet operational commitments. - assigning the maintenance military personnel - in case of emergency or accident, revise the repairing of the damaged aircraft so that the flight/operations schedules are not affected. Quality Assurance - Responsible for testing of the various parts and systems to verify if they meet the quality standards. - Performing end-of-runway, postflight, preflight, thru-flight and phase inspections. - Diagnosing and solving maintenance problems on aircraft systems. - Interpreting and advising on maintenance procedures to repair aircraft and related equipment - Interpreting inspection findings and determining necessary corrective actions and/or preventive actions. - Inspecting the components for, proper installation and operation. Reporting - collecting information regarding the repair and maintenance performed. - View and reviews maintenance forms, aircraft records, automated maintenance data systems, and historical reports to ensure complete documentation. Cost Reducing - compiling the expenses and total time consumed for the maintenance process. - providing cost effective solutions and reduce unnecessary expenses. Recruitment and Training - training basic and special military skills of new recruits Show less