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(Updated 2024-03-10)Quality Management Systems Manager
Allerød, Denmark
Native English, Portuguese, Intermediate Danish
- +10 years experience in LEAN and Six Sigma
- +15 years experience in Operations Management
- +15 years experience within QMS (medical devices and pharmaceuticals)
Skills (26)
BUSINESS MANAGEMENT
CHANGE CONTROL
DMS
DOCUMENTATION
AUDIT
Project Management
TECHNICAL DOCUMENTATION
QUALITY ASSURANCE
PROBLEM SOLVING
Six Sigma
JMP
QUALITY SYSTEM
MAPPING
Quality Systems Management
COACHING
AUDITS
CUSTOMER SURVEYS
MINITAB
SIX-SIGMA
Aseptic Production
Assembly
FDA
CONSUMER SURVEYS
TOPO
SAS
Serial Attached SCSI
Professional Experience
Senior Project Management
NOVO NORDISK
2023-07 - Present
Capacity improvement projects in IFP Aseptic Production sites
Senior Manager
DEVICE MANUFACTURING AND SOURCING
2022-07 - 2023-07
Manager for DMS Quality Support team, responsible for: - Handling of customer complaints and deviations related to prefilled and durable devices for all Novo Nordisk (injection moulded and metal components, electronics and assembled devices) in a global context - Local implementation of quality requirements related to customer complaints and deviation handling - Coaching of employees on LEAN methodologies (A3 / Systematic problem solving, process / value stream mapping and DMAIC) - Execution of LEAN projects (A3 / Systematic problem solving, process / value stream mapping and DMAIC)
Associate Manager
2021-05 - 2022-07
Head of Production Support & Improvement team in DMS Moulding covering activities related to: - Quality support (deviations, internal complaints and quality monitoring) - Injection moulds spare parts management - Improvement projects related to quality, OEE and EHS - Coaching of employees on LEAN projects (A3 / Systematic problem solving, process / value stream mapping and DMAIC)
LEAN Project Manager
2020-03 - 2021-05
- Management of high complexity improvement projects (DFSS / DMAIC) - Training and coaching of employees and leaders on LEAN tools and their application (A3 / Systematic problem solving, value stream mapping, visual management, DMAIC, etc.)
Quality Support Engineer
2016-03 - 2020-03
Handling of complaints (nonconformities / deviations and customer complaints) related to DMS production (internal and external) through use of systematic problem solving tools (SPS) to determine causes and countermeasures.
- Mediation between internal and external stakeholders during complaint handling.
- SPS coaching in A3s and trainer of external suppliers in SPS tools.
- One Point of Entry in DMS for complaints related to DMS products observed internally or externally (at supplier, assembly sites or from the market).
- System owner responsible for processes related to complaints towards DMS.
- System owner responsible for the training and requalification of DMS external suppliers in in process control of plastic components.
- Mediation between internal and external stakeholders during complaint handling.
- SPS coaching in A3s and trainer of external suppliers in SPS tools.
- One Point of Entry in DMS for complaints related to DMS products observed internally or externally (at supplier, assembly sites or from the market).
- System owner responsible for processes related to complaints towards DMS.
- System owner responsible for the training and requalification of DMS external suppliers in in process control of plastic components.
Quality Assurance Manager
GERRESHEIMER MEDICAL PLASTIC SYSTEMS
2012-10 - 2016-02
- Quality representative among customers.
- Development and support to continuous improvement projects (six sigma, FMEA and DFQ) related to quality, production and quality control.
- Quality system management in regards to regulations such as ISO13485, ISO9001, Good Manufacturing Practices and customer specific requirements.
- Planning, execution and attendance of internal and external audits (national and international).
- External / internal non conformity management applying quality tools such as 5W2H, Ishikawa, 5 times why, 8D reports, etc.
- Product and services validation in regards to internal and external requirements.
- Management of new projects / change control of existent products and services: resource planning, planning and development / adequation of processes in order to attend new or modified requirements.
- Management and operational trainings.
- Quality document management.
- Team leader of in process control team for visual and dimensional analysis of plastic components.
- Development and support to continuous improvement projects (six sigma, FMEA and DFQ) related to quality, production and quality control.
- Quality system management in regards to regulations such as ISO13485, ISO9001, Good Manufacturing Practices and customer specific requirements.
- Planning, execution and attendance of internal and external audits (national and international).
- External / internal non conformity management applying quality tools such as 5W2H, Ishikawa, 5 times why, 8D reports, etc.
- Product and services validation in regards to internal and external requirements.
- Management of new projects / change control of existent products and services: resource planning, planning and development / adequation of processes in order to attend new or modified requirements.
- Management and operational trainings.
- Quality document management.
- Team leader of in process control team for visual and dimensional analysis of plastic components.
FMEA
2013-01 - 2013-01
● Measurement systems validation (2010) ● Computerized systems validation (2009) ● Analytical uncertainty (2007)
Quality Specialist
2012-02 - 2012-10
- Development and implementation of visual and dimensional analytical methods.
- Optimization of analytical methods.
- Planning, execution and documentation of validation and periodic revalidation of analytical methods.
- Planning, execution, evaluation and documentation of statistical studies.
- Planning and attendance of internal and external audits.
- Internal non conformity management applying quality tools such as 5W2H, Ishikawa, 5 times why, 8D reports, etc.
- Monitoring of measurement systems reliability applying statistical techniques.
- Product release.
- Optimization of analytical methods.
- Planning, execution and documentation of validation and periodic revalidation of analytical methods.
- Planning, execution, evaluation and documentation of statistical studies.
- Planning and attendance of internal and external audits.
- Internal non conformity management applying quality tools such as 5W2H, Ishikawa, 5 times why, 8D reports, etc.
- Monitoring of measurement systems reliability applying statistical techniques.
- Product release.
Regulatory issues Analyst / Quality
CONTECH BIODEGRADABLE PRODUCTS
2011-03 - 2011-08
Conformity evaluation of products and services in regards to pulp and paper market regulations (FDA, ANVISA, EU and customer specific requirements).
- Technical documentation adequation in regards to ABNT NBR 14725 / GHS requirements.
EMS - BRAZIL
- Technical documentation adequation in regards to ABNT NBR 14725 / GHS requirements.
EMS - BRAZIL
Chemist - R&D projects supervisor
2010-10 - 2011-02
Management of DMF (Drug Master Files) adequation projects for drugs active ingredients in regards to the national regulatory requirements (development of international drug active ingredients suppliers).
- Quality Control / Analytical Methods Validation department support on the development of analytical methodologies and specifications for drugs, excipients and packaging materials based on suppliers and pharmacopeical recommendations.
- Quality Control / Analytical Methods Validation department support on the development of analytical methodologies and specifications for drugs, excipients and packaging materials based on suppliers and pharmacopeical recommendations.
Chemist - Quality Systems Assistant
RHODIA POLIAMIDA E ESPECIALIDADES LTDA
2007-01 - 2010-08
- Development, implementation and optimization of analytical methods.
- Planning, execution and documentation of validation and revalidation of analytical methods.
- Management of proficiency testing and interlaboratory programs.
- Attendance on internal and external audits (ISO 9001, ISO 14001, ISO 17025 and Good Manufacturing Practices).
- Non conformity resolution.
- Operational team trainings.
- Management and evaluation of stability studies of pharmaceutical additives based on ANVISA requirements.
- Management, preparation and approval of quality documents and records.
- Process statistical control of quality results.
- Planning, execution and statistical evaluation of of customer surveys.
- Development of Six Sigma projects related to Quality Control and Production.
- Analytical control of raw material, semi-finished and finished goods, water and effluents.
- Planning, execution and documentation of validation and revalidation of analytical methods.
- Management of proficiency testing and interlaboratory programs.
- Attendance on internal and external audits (ISO 9001, ISO 14001, ISO 17025 and Good Manufacturing Practices).
- Non conformity resolution.
- Operational team trainings.
- Management and evaluation of stability studies of pharmaceutical additives based on ANVISA requirements.
- Management, preparation and approval of quality documents and records.
- Process statistical control of quality results.
- Planning, execution and statistical evaluation of of customer surveys.
- Development of Six Sigma projects related to Quality Control and Production.
- Analytical control of raw material, semi-finished and finished goods, water and effluents.
QUALITY SYSTEMS MANAGEMENT
2010-01 - 2010-01
Good Manufacturing Practices
2010-01 - 2010-01
TECHNICAL
Internship researcher
CHEMICAL STATE CHEMISTRY LABORATORY - CHEMICAL INSTITUTE, UNICAMP
2005-01 - 2007-01
Inorganic synthesis, physical-chemical characterization of solid material, structural modification of solids, analytical analysis of solids.
EXTRA CURRICULAR COURSES LEAN ● Six Sigma Black belt (2020) ● A3 / Systematic Problem Solving (2017) ● Six Sigma Green Belt (2010) PROJECT MANAGEMENT ● Agile (2021) ● Managing without authority (2016) ● DMAIC (2020) BUSINESS MANAGEMENT ● Costs management (2011) ● Quality on services (2011) ● Balanced scorecard (2011)
EXTRA CURRICULAR COURSES LEAN ● Six Sigma Black belt (2020) ● A3 / Systematic Problem Solving (2017) ● Six Sigma Green Belt (2010) PROJECT MANAGEMENT ● Agile (2021) ● Managing without authority (2016) ● DMAIC (2020) BUSINESS MANAGEMENT ● Costs management (2011) ● Quality on services (2011) ● Balanced scorecard (2011)
Academic Background
MBA
Fundação Getúlio Vargas (FGV)
2024-03 - 2015-12
Universidade Estadual de Campinas (Unicamp)
Universidade Estadual de Campinas (Unicamp)
2024-03 - 2008-06
Certifications
Six Sigma Black belt