
Susanne Bach Schmidt

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About me
Senior Director Quality Assurance
Education

DI´s Lederuddannelse
2019 - 2020DI's management education is a practice-oriented education in Leadership; here training and to trying out different management tools. The Leadership education consists of 6 modules, to gain knowledge and experiencing different management tools and to implement these in the daily work including but not limited to:• To motivate, coach and develop employees.• Setting clear goals, delegating tasks, and breaking down objectives into clear actions so you can achieve the company's business… Show more DI's management education is a practice-oriented education in Leadership; here training and to trying out different management tools. The Leadership education consists of 6 modules, to gain knowledge and experiencing different management tools and to implement these in the daily work including but not limited to:• To motivate, coach and develop employees.• Setting clear goals, delegating tasks, and breaking down objectives into clear actions so you can achieve the company's business goals.• To communicate. • To lead change processes and manage conflicts in the organization.• To develop and lead a team effectively.• Managing pressure and preventing stress at work. Show less

Three Circles
2017 - 2017Risk Management for Medical Devices EN 14971:2012Course designed for engineers, technicians, and professionals focusing on product and process risk including but not limited to common risk-management methods used in product design and manufacturing processes. Using case studies and interaction, you will practice identifying and analyzing potential product and process hazards, FMEA, hazard and Fault Tree Analysis, Hazard and Critical Control Point, and all the critical skills needed to create a risk management plan, process, report and file… Show more Course designed for engineers, technicians, and professionals focusing on product and process risk including but not limited to common risk-management methods used in product design and manufacturing processes. Using case studies and interaction, you will practice identifying and analyzing potential product and process hazards, FMEA, hazard and Fault Tree Analysis, Hazard and Critical Control Point, and all the critical skills needed to create a risk management plan, process, report and file. The illustration of commonly used risk-identification and risk-reducing methods and practical applications implementing tools relevant and applicable to medical device risk management related to ISO 13485, 21 CFR 820, and IEC 62366. Show less

Bureau Veritas
2016 - 2016ISO 13485:2016 upgrading seminarn brief; obtaining knowledge of the process-oriented standard ISO 13485:2016 regarding to management systems in the medical device industry. Course objectives:• An understanding of the key requirements of ISO 13485.• An understanding of the philosophy behind the standard, and the approaches to quality management.• An understanding of the basic ISO 13485 concepts.• An understanding of the potential benefits of implementation of ISO 13485.• Internal auditing concepts, methods,… Show more n brief; obtaining knowledge of the process-oriented standard ISO 13485:2016 regarding to management systems in the medical device industry. Course objectives:• An understanding of the key requirements of ISO 13485.• An understanding of the philosophy behind the standard, and the approaches to quality management.• An understanding of the basic ISO 13485 concepts.• An understanding of the potential benefits of implementation of ISO 13485.• Internal auditing concepts, methods, and practices. Show less

Implement
2014 - 2015Project Management AdvancedPM1: Manage your projectPM2: Lead your project teamPM3: Succeed with you projectPM4: Strengthen your personal leadership in projects

Scrum Alliance
2012 - 2013Scrum master
HGV at Køge Business school
2006 - 2008office assistant with special focus on administration. Final project about "Work/Life balance" awarded with top grade.

Solrød gymnasium
1991 - 1994Linguistic student.
Ecole europenne Uccle
1983 - 1991
SQT Training Ltd
2017 - 2017Medical Device FDA QSR & QSITIntroduction to US FDA Quality System Regulation [QSR] : 21 CFR PART 820Medical Device FDA guidance documentsAn Introduction to QSITQSR Subpart A - General Provisions, Subpart B - Quality System RequirementsQSIT approach to auditing Management ControlsSubpart C - Design ControlQSIT approach to auditing Design ControlsQSR Subpart D - Document Controls, Subpart E - Purchasing Controls & Subpart F - Identification & TraceabilityQSR Subpart G - Production and Process… Show more Introduction to US FDA Quality System Regulation [QSR] : 21 CFR PART 820Medical Device FDA guidance documentsAn Introduction to QSITQSR Subpart A - General Provisions, Subpart B - Quality System RequirementsQSIT approach to auditing Management ControlsSubpart C - Design ControlQSIT approach to auditing Design ControlsQSR Subpart D - Document Controls, Subpart E - Purchasing Controls & Subpart F - Identification & TraceabilityQSR Subpart G - Production and Process ControlsQSIT approach to auditing Production & Process ControlsQSR Subpart H - Acceptance Activities, Subpart I - Nonconforming Product & Subpart J - Corrective and Preventive ActionQSIT approach to auditing Corrective & Preventive actionQSR Subpart K - Labelling and Packaging Control & Handling, Storage, Distribution & InstallationQSR Subpart M – Records, Subpart N – Servicing & Subpart O - Statistical TechniquesPreparing for an FDA AuditMedical Device Vigilance for Manufacturers Show less
Experience

Sonion Medical
Mar 2008 - Feb 2012- Sparring partner for the management team- Secretary for the management team- Chief Editor of worldwide employee magazine- Optimisation of administrative processes- Project status coordination- Minutes of meetings- Coordination of meeting facilities and bookings- Travel booking- 5S coordinator- Raw material sourcing- Purchase (raw) material specifications- Change Request documentation - Project coordination - Support for project managers and participants - Personal assistant to R&D Director - Execution of purchase orders - Follow up of Change Requests - Invoice registration - Budget follow-up - Calendar management
Management Coordinator
Jan 2011 - Feb 2012Project assistant
Mar 2008 - Dec 2010

SP Medical A/S
Jan 2012 - Jan 2013Project Coordinator
Unomedical
Jan 2013 - Jan 2022In general• Ensure constant development and maintenance of the quality management system (QMS).• Ensure that the QMS is in compliance with regulatory requirements in the countries where the company´s products are marketed.• Ensure simplification of procedures and processes, so the QMS always aims at and reflects best practice.• Ensure quality awareness throughout the organisation e.g. via training and education of employees in quality assurance and control.• Ensure and develop customer communications in relation to quality aspects.Responsibility• Approve documents in the QMS as QA Manager (formalities, system coherence, standards etc) • Develop quality procedures and processes, where necessary in close cooperation with corporate RA/QA• Ensure coherence and structure in the documents of the QMS• Ensure that all elements and requirements in relevant standards are implemented and maintained in the QMS• Plan and carry through training of employees in the QMS• Aim at simplification of the procedures in the QMS, so they are value adding and reflect best practice• Maintenance of Quality Manual, Cross Reference lists between QMS and applicable standards/regulation, DMRs and List of Standards.• Responsible for DHF after Design TransferAudits• Ensure that internal audit are performed for all areas of the quality system. • Participate in planning and completion of external audits (Notified Body, Authorities, Customers) Show less In general• Develop, maintain and modify the project documentation.• Ensure the presence of the necessary documentation for projects to be in compliance with internal procedures and standards.• Handle the documentation in the documentation management system.• Perform the documentation according to Unomedical Documentation Standard.• Develop, maintain and ensure compliance with procedures, instructions and templates for projects - especially in connection with the preparation of project documentation.• Take responsibility for developing and ensuring cooperation and knowledge sharing in the projects and the team.Documentation: • Perform all forms for documentation according to the Change Control procedure, and in general be in compliance to the Unomedical documentation standards. • Contribute with information to the establishment or change of the technical project/product documentation; ECO/ECR, BOM, Material specifications, test specifications etc.Cooperation and communication:As technical documentation supporter there is a big cooperation with other departments within the organization. Therefore it is important to establish a good cooperation, including providing the necessary and correct information in time and be able to participate in cross-organizational groups and project teams. Show less
Regulatory Affairs Team Manager
Oct 2019 - Jan 2022QMS manager
Apr 2016 - Jan 2022Dokumentationsansvarlig
Jan 2013 - Apr 2016

SPT VILECON
Jan 2022 - Oct 2023Head of QA/QC and RA at SPT Vilecon
Demant
Nov 2023 - nowSenior Director Quality Assurance
Licenses & Certifications

Lead auditor ISO 13485:2016
MedicoindustrienNov 2018
Lead Auditor ISO 9001:2015
FORCE TechnologyOct 2016
Honors & Awards
- Awarded to Susanne Bach SchmidtMDR implementation ConvaTec 2021
- Awarded to Susanne Bach SchmidtMDSAP implementation ConvaTec 2018
Volunteer Experience
Stafet for livet kaptajn
Issued by Kræftens Bekæmpelse (Danish Cancer Society) on Jan 2016
Associated with Susanne Bach Schmidt
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