Juliana Ribeiro de Almeida
Schwerzenbach
Summary
Quality Manager with a unique blend of continuous improvement in process, production and quality management. Manager of actions to ensure quality improvement of the supply chain, establishing procedures, reviewing customer requirements, establishing quality requirements, setting internal standards, defining quality procedures, monitoring performance and implementing actions for improvement. Quality Manager with a strategic and forward thinking, with good communication skills and leadership. Professional with good knowledge of quality control procedures and quality standards. Adaptable Quality Manager with 10 years background in implementing and developing improvement processes through collaboration with cross-functional teams. First-rate computer, analysis and research skills. Specialties include achieving set targets, generating new strategies and maintaining accurate records. Resourceful Manager offering history of success coordinating and monitoring operations across various departments. Effective leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Highly committed with hardworking mentality to maintain quality of services and products.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Quality Manager
IMT AG
04.2022 - Current
- Quality Manager responsible for the supply chain related to quality assurance from the Life Sciences and Medical products
- Organizing, conducting and documenting intern, supplier and client’s Audits
- Coordination of improvement projects; from receiving inspection, production to product shipment and from the quality management system
- Working with internal and external complaints in order to improve quality of production processes and final products.
Senior Product Maintenance Engineer
Biotronik AG
11.2016 - Current
- Manager of the project to qualify and validate a new supplier for the drug to coat the balloon family products
- Coordinator the "Change Management" process to adapt the products and production documents
- Engineer working with the Regulatory Affairs department during product submissions, change and re- certification projects to reduce regulatory risk.
Validation Engineer
Biotronik AG
08.2015 - Current
- Lead and project managed CAPA to resolve deficiency from notified body in critical quality process
- Moderator of Risk Management Analysis (FMEA)
- Lead execution of process validation and provided guidance and assistance regarding execution of validation projects.
Quality Engineer
Biotronik AG
02.2014 - Current
- Actively monitoring of the effectiveness of processes and quality of the peacemaker production and propose and execute quality/process improvements
- Actively participation from audits to clarify regulatory and production questions
- Assistant production with day-to-day plant issues.
R&D Project Manager
SIS Medical
04.2021 - 02.2022
- Project Manager of the 510(k) FDA regulatory submission from the main PTCA catheter from SIS Medical
- Project Manager of quality improvement from the main PTCA catheter from SIS Medical
- Manager of quality activities such as CAPA, FSCA , management review, change control, documentation control, validation and traceability.
Project Manager
Biotronik AG
02.2014 - 03.2021
- Project Manager of the automation and digitalization of the assembly line of the drug coated balloons
- Project Manager of the automation of the second generation of the automation from the coating of stents
- Implementing project management guidelines for automation projects to comply with GMP and quality management system.
Project Engineer
Skan AG
07.2012 - 01.2014
- Responsible for process validation of Skan isolators at the company and client's site
- Provider of training of personnel and customers for the EO- sterilization using Isolators
- Statistics specialist from qualification process – DoE.
Education
Master of Sciences - Environmental Sciences
Federal Institute of Technology Zurich
Zurich01.2012
Engineering Bachelor - Environmental Engineer
Federal University of Paraná
Curitiba, Brazil01.2008
Bachelor - Mathematics
Catholic University of Paraná
Curitiba, Brazil01.2006
Skills
- Project planning software (MS Project, Project Libre, Sciforma, Confluence, Jira)
- Microsoft Office Suite (including visio, powerpoint, sharepoint, excel, etc)
- Statistical Analysis Software (Minitab, Design Expert)
- MES, PAC
- Windows Operating System (7, 10)
- Electronic Documentation Management (TIS, SAP)
- Quality Management (Q-Studio, SAP, ETQ Reliance)
- Production Controlling (iScala, Outputmanager)
- Quality Management Systems
- Compliance Monitoring
- Corrective Actions
- Document Management
Certification
- Interner Auditor, SAQ-Qualicon, Olten, 08/01/22
- Projektmanagement: Methoden & Instrumente, BWI Betriebswissenschaftlisches Institut, Zurich, 03/01/17
- Projektmanagement: Führung von Projekt und Team, BWI Betriebswissenschaftlisches Institut, Zurich, 11/01/18
- Komunikations-und Gesprächstraining, BWI Betriebswissenschaftlisches Institut, Zurich, 06/01/16
- Minitab: Statistischen Datenanalyse, Statistische Messsystemanalyse und DoE, Addictive Academy, Zurich, 06/01/15
- Daten integrität, Alphatopics, Zurich, 12/01/15
- ISO 13485 -Grundlagenwissen, TQM.com Totally Quality Management, Zurich, 07/01/14
Languages
Portuguese (mother tongue)
German (fluent)
English (fluent)
French (fluent)
Residence Permit
Type C
Relevant Competencies
- Design of Experiments (DOE, Six Sigma).
- LEAN, 5S
- Process, Equipment and Test Method Validation
- Complaint Management (internal and external)
- Measurement System Analysis.
- Statistical Process Control (SPC)
- Quality Management (SOPs, WIs)
- Corrective and Preventative Action (CAPA)
- Field Safety Corrective Action (FSCA)
- 21CFR Part 11, Part 820
- ISO 13485
- ISO 2001:2015
- FDA and CE class III medical device submission process.
Personal Information
Nationality: Brazilian
Working permit: C
Timeline
Quality Manager
IMT AG
04.2022 - Current
R&D Project Manager
SIS Medical
04.2021 - 02.2022
Senior Product Maintenance Engineer
Biotronik AG
11.2016 - Current
Validation Engineer
Biotronik AG
08.2015 - Current
Quality Engineer
Biotronik AG
02.2014 - Current
Project Manager
Biotronik AG
02.2014 - 03.2021
Project Engineer
Skan AG
07.2012 - 01.2014
Master of Sciences - Environmental Sciences
Federal Institute of Technology Zurich
Engineering Bachelor - Environmental Engineer
Federal University of Paraná
Bachelor - Mathematics
Catholic University of Paraná
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