Monika Weber
Quality Specialist
Experience
Mar 2025 - Sep 2025
7 monthsQuality Specialist
Nexans GmbH
- Implemented a quality management system including all needed process descriptions and work instructions for ISO 9001:2015 certification and planned and led the audits
- Created action catalogs for steps needed to meet ISO 9001 and achieve certification
- Wrote ISO 9001 documentation
- Developed training materials for staff and managers based on the QMH and other documents
- Logged results of external audits of departments (incoming goods, production, warehouse logistics, procurement and supplier management, outgoing goods, shipping) per ISO 9001
- Prepared for and took part in certification audit
Oct 2024 - Jan 2025
4 monthsProject Manager Medical Devices
Merz Aesthetics GmbH
- Led FDA Pre-Approval Readiness
- Broke down tasks into work packages
- Created, reviewed, maintained and updated GCP and other quality documents
- Developed a new issue management and EM monitoring process
- Point of contact for CAPAs, audits, deviations, SOPs and risk analyses
- Supported change management, complaint handling and issue management
- Conducted trainings
- Supported departments in audits and inspections
- Collaborated across departments
Apr 2024 - Oct 2024
7 months Melsungen, Germany
Consultant Change Management
B.Braun Melsungen AG
- Handled change requests in the electronic Change Control system
- Managed changes in the system
- Generated reports for R&D Change Management
- Supported project management
- Organized change control processing
- Coordinated change control, tracked progress and tasks in the system
- Planned and led kick-off meetings
- Wrote memos to file
- Reviewed reports
- Coordinated and tracked MDR-relevant changes
Sep 2023 - Mar 2024
7 monthsInterim Quality Manager
Calibre Scientific GmbH / Biozol
- Set up a quality management system including all required process descriptions and work instructions for medical devices in cell technology and various lab products for ISO 13485 certification, then planned and led ISO 13485, MDR and IVDR audits
- Created action catalogs for steps needed to meet ISO 13485, MDR and IVDR requirements and achieve certification
- Wrote ISO 13485 and MDR documentation
- Reviewed and updated quality agreements with suppliers
- Performed supplier audits per ISO 13485
- Developed training materials based on quality manuals and documents
- Logged external audits of departments (incoming goods, production, warehouse logistics, procurement and supplier management, outgoing goods, shipping) per ISO 13485 and MDR
- Compiled technical documentation
- Monitored safety profiles of medical and test products
- Conducted medical/pharmacological case reviews including trend analysis and risk assessment
- Performed PMCF studies
- Initiated CAPAs or updated risk analyses and IFUs based on data analysis
- Reported to authorities and notified bodies
- Compiled safety information and reports (PMS reports, Post Clinical Follow-Up reports, summary reports on safety and performance)
- Monitored market per ISO 14971, ISO 13485, MDR (EU 2017/745) and IVDR (EU 2017/746)
- Supported clinical trials and dev team with documentation
- Aided registration applications and life-cycle management for medical devices and CE marking renewals
- As expert, supported MedDRA/IMDRF coding
- Prepared for and joined MDV and ISO 13485:2021-12 and MDSAP audits
Jun 2023 - Dec 2023
7 months Lorem ipsum dolor sit amet
Inosolve Consulting GmbH
- Advised on creation of Product Quality Reviews for solids and liquids
- Reviewed Product Quality Reviews
- Supported the drafting of Product Quality Reviews
- Helped gather IPK data and create graphs
- Assisted in writing stability reports
Jan 2022 - Mar 2023
3 monthsGMP Expert
Levano Med GmbH
- Reviewed existing SOPs
- Advised on needed SOPs
- Revised the QMH/SMF
- Consolidated documentation
- Verified documents against regulatory requirements for solids and liquids
Jun 2021 - Jul 2023
2 years 2 monthsSenior CSV Specialist
Miltenyi Biotec B.V. & Co. KG
- Planned and conducted CSV to fully complete validation documentation in IT systems per ISO 13485, 21 CFR 820 and Part 11
- Created as-is analysis of existing CSV via SharePoint tool
- Ran CSV in SAP environment
- Prepared monthly project reports and presentations with MS Project
- Reviewed validations per ISO 13485, FDA and GMP requirements
- Produced full validation documentation
- Assisted in preparing validation docs in various SAP projects
- Wrote work instructions and training slides for SAP CSV
- Created full validation docs for SAP BAS
- Authored SOP for User Authorization and Security Concept for SAP
- Developed concept for digitizing SAP CSV
- Designed validation concept tailored for SAP CSV
- Wrote risk analyses and traceability matrices
- Held status meetings for SAP CSV
- Developed a new validation process for SAP CSV including SOPs, work instructions, good documentation practice and training docs, and updated all existing validation docs to prep migration to the new SAP CSV digital tool
- Managed NC/CAPAs
- Conducted root cause analyses
- Tracked and reported KPIs
- Implemented improvements and corrective actions
Mar 2021 - Present
4 years 5 monthsInterim Quality Manager
Biobedded Systems GmbH
- Updated QMS per DIN EN ISO 13485:2021 to fit evolving team
- Aligned and harmonized core QMS processes to ensure and improve quality and process stability
- Created and revised quality management processes
- Managed process owners’ activities to ensure process compliance
- Standardized and digitized processes to boost effectiveness
- Revised, reviewed and optimized workflows in Confluence
- Wrote training docs and delivered trainings
- Prepared and maintained project docs for annual audits in Jira/Confluence
- Supported test engineers in app validation
- QMS representative
- Advised on and supported CSV
- Managed compliance and risk
- Produced technical documentation
- Handled usability processes per IEC 62366-1
- Ensured compliance with DIN EN ISO 62304 and 14971
- Drafted a quality manual
- Integrated MDR requirements into ISO 13485:2021
- Wrote procedures and work instructions
- Turned QMS guidelines into workable processes
- Developed and implemented QMS-focused project management processes
- Handled CAPA management
- Advised on MDR, ISO 13485 and MPG standards
- Updated existing and created new procedures and work instructions
- Helped implement changes
- Designed processes to meet quality goals and ensure compliance through all development tasks, reviewed interfaces for quality, and improved as needed
- Conducted risk analyses
- Ran computer system validations
Jan 2020 - Feb 2020
2 monthsAuditor
Freelance
- Internal and supplier audits
- Medical devices: ISO 13485, MPG, MDR, MDD, ISO 14971, DIN EN ISO 62304
- Pharmaceutical industry: GMP, GDP, GLP, GxP
- Chemical industry: ISO 9001
May 2019 - Dec 2020
1 year 8 monthsSenior CSV Specialist
Richard Wolf GmbH
- Validation Lead – reviewed and approved validation docs
- Ensured compliance with ISO 13485, MPG and MDR; advised and supported technical documentation
- Managed compliance and risk
- Handled change management including release planning
- Scoped and implemented new SAP modules and carried out CSV
- Performed risk analyses per ISO 14971
- Ensured compliance with DIN ISO 62304
- Planned and executed CSV per GAMP 5 and GxP
- Wrote project reports and presentations
- Drafted process descriptions for IT gap analyses and risk analyses
- Delivered trainings
- Led validation projects
- Supported process development to meet quality standards in development
Jan 2019 - Apr 2019
4 monthsAuditor
Freelance
- Internal and supplier audits
- Medical devices: ISO 13485, MPG, MDR, MDD, ISO 14971
- Pharmaceutical industry: GMP, GDP, GLP, GxP
- Chemical industry: ISO 9001
Oct 2018 - Dec 2019
3 monthsDocument Specialist
Pharma / client anonymous
- Created and executed CSV
- Managed compliance and risk
- Aligned and harmonized core QMS processes to ensure and improve quality and stability
- Developed and revised QMS processes
- Managed process owner activities to ensure compliance
- Standardized and digitized processes to improve efficiency
- Optimized workflows in Confluence
- Wrote training docs and led trainings
- Prepared and maintained project docs for annual audits in Jira/Confluence
- Wrote full documentation for process validation in solid production
- Performed gap analysis of existing validation docs
- Validated processes, cleanroom and development for solid production and revalidation
- Reviewed batch records
- Created and updated work instructions
- Wrote and updated SOPs, forms and change requests (CCR)
- Supported maintaining GMP status in pharma manufacturing (deviations, error investigation reports)
- Ran CAPA processes, recorded CAPAs and managed change control
- Conducted risk analyses
- Trained employees
- Prepared FDA audit
Aug 2018 - Aug 2018
1 monthChange Control Consultant
Pharma / client anonymous
- Managed CAPA and root cause analyses
- Handled compliance management and KPI tracking/reporting
- Managed risk
- Coordinated and oversaw change controls (German and/or English)
- Aligned and updated documents per approvals
- Assigned necessary tasks for each change
- Ensured timely handling of changes
May 2018 - Jul 2018
3 monthsInterim Quality Manager
Medical Device / client anonymous
- Advised on and supported CSV
- Managed compliance and risk
- Produced technical documentation
- Aligned and harmonized core QMS processes to ensure and improve quality and stability
- Developed and revised QMS processes
- Managed process owner activities to ensure compliance
- Standardized and digitized processes to improve efficiency
- Optimized workflows in Confluence
- Wrote training docs and led trainings
- Prepared and maintained project docs for annual audits in Jira/Confluence
- Handled usability processes per IEC 62366-1
- Prepared for ISO 9001:2015 recertification
- Wrote a quality manual per ISO 9001:2015 and ISO 13485
- Conducted internal audits including reports and follow-up
- Managed CAPAs
- Advised on MDD, ISO 13485 and MPG standards
- Updated existing SOPs and wrote new ones
- Supported ISO 9001:2015 certification audit
- Helped implement changes
- Designed processes to meet quality requirements
- Ensured compliance review of all dev tasks for quality, checked interfaces and improved
- Ran risk analyses
- Managed NC/CAPA
- Conducted root cause analyses
- Tracked and reported KPIs
- Implemented improvements and corrective actions
Feb 2018 - May 2018
4 monthsRegulatory Affairs Consultant
Pharma / client anonymous
- Regulatory Affairs Consultant
- Created validation documentation
- Managed compliance and risk
- Advised project teams on FDA and other authorities’ regulatory requirements in meetings
- Aligned and harmonized core QMS processes to ensure and improve quality and stability
- Developed and revised QMS processes
- Managed process owner activities to ensure compliance
- Standardized and digitized processes to improve efficiency
- Optimized workflows in the QMS system
- Managed NC/CAPA and root cause analyses
- Tracked and reported KPIs
- Implemented improvements and corrective actions
- Wrote training docs and conducted trainings
- Prepared and maintained project docs for annual audits in Jira/Confluence
- Prepared and supported an FDA audit
- Commissioned quality document creation
- Coordinated quality doc production by departments
- Reviewed quality docs
- Drafted regulatory documents per relevant guidelines
- Managed risk
- Created and implemented changes
- Wrote a user manual for new SAP BI modules in BEX Analyzer
Jul 2017 - Dec 2017
6 monthsAudit Assistant
Freelance
- Audit assistant
- Supported various audits as assistant: APEX, IECEx, ISO 9001:2008
Jul 2017 - Dec 2017
6 monthsQuality Management Consultant
Pharma / client anonymous
- Performed gap analysis for GMP-compliant archiving of all documentation
- Managed compliance, NC/CAPA
- Conducted risk management and root cause analyses
- Aligned and harmonized core QMS processes to ensure and improve quality and stability
- Developed and revised QMS processes, KPI tracking and reporting
- Managed process owner activities to ensure compliance
- Standardized and digitized processes to improve efficiency
- Optimized workflows in the QMS system
- Wrote training docs and led trainings
- Prepared and maintained project docs
- Advised project teams on regulator and authority (EMA, FDA, LAGeSo) requirements in meetings
- Prepared and supported FDA and LAGeSo audits
- Reviewed change-control requests in the system per SOPs
- Conducted CSV
- Coordinated quality doc production by departments
- Reviewed quality docs
- Drafted regulatory docs per guidelines
- Qualified and validated lab equipment
- Reviewed test method validation
- Helped implement changes
- Advised on APQR and change control
- Built or updated the QMS
- Supported GMP inspections
- Ran internal audits
- Managed CAPA
- Qualified the supply chain and coordinated audits
- Supported GMP integration and compliance for inspections
- Advised on GMP, GDP, GLP, MPG
- Performed gap analysis and created remediation plans
- Managed risk and FMEAs, compliance checks
Mar 2016 - Mar 2017
1 year 1 month Seelze, Germany
Quality Manager Operations
Honeywell Seelze GmbH
- Led quality strategy execution in Supply Chain (logistics and packaging)
- Managed compliance and risk
- Oversaw quality strategy for pigments and overall logistics
- Aligned and harmonized core QMS processes to ensure and improve quality and stability
- Developed and revised QMS processes
- Managed process owner activities to ensure compliance
- Standardized and digitized processes to improve efficiency
- Wrote training docs and led trainings
- Reviewed QA documents
- Supported CAPA tracking
- Qualified suppliers and managed them
- Aided in change control
- Helped review logbooks
- Assisted with deviations
- Handled NC/CAPA and root cause analyses
- Prepared and supported an FDA audit
- Ran QM measures and enhanced the integrated QM system per ISO 9001, GMP, MPG and other norms
- Improved quality processes
- Initiated, reviewed and approved deviation investigations
- Stopped production when quality was at risk
- Supported GMP safety info reviews
- Advised project teams on EMA, FDA, LAGeSo requirements in meetings
- Reviewed change-control requests per SOPs
- Commissioned quality doc creation and coordinated with departments
May 2015 - Feb 2016
10 monthsQuality Management Representative
Eckert & Ziegler Strahlen- und Medizintechnik AG; Eckert & Ziegler Nuclitec GmbH; Eckert & Ziegler Umweltdienste GmbH
- Carried out quality measures and contributed to integrated QMS development (ISO 9001, ISO 13485, KTA, GMP, GDP, GLP)
- Managed NC/CAPA and root cause analyses
- Supported QA tasks in other departments
- Facilitated working groups
- Documented processes, tracked and reported KPIs
- Performed and reported internal and supplier audits
- Planned and delivered quality management trainings
- Conducted feasibility and failure analyses
- Defined continuous improvement measures
- Prepared and supported ISO certification audit
- Handled class II and III registration applications
- Aligned and harmonized core QMS processes to ensure and improve quality and stability
- Developed and revised QMS processes
- Managed process owner activities to ensure compliance
- Standardized and digitized processes to improve efficiency
- Wrote training docs and led trainings
- Prepared and maintained docs for annual audits
Aug 2013 - Nov 2013
4 monthsProject Management Assistant
Randstad
- Attended and ran meetings, carried out action items
- Coordinated and took responsibility for projects
- Organized alignment processes inside and outside the company
- Reviewed and processed contracts for business and legal aspects
- Scheduled and organized meetings, documented and shared minutes
- Supported project leads with admin and org tasks
- Maintained and ensured data quality in project database; created and updated org charts and presentations; ensured formal correctness of project docs
- Distributed info and reported (project plans, status reports); made and updated effort and schedule plans and related reports; prepared steering committee materials
- Handled project controlling
- Collected, managed and checked timesheets
- Maintained resource overview (plan vs. actual)
- Monitored and updated project risk list
- Managed and tracked open-item list
- Kept attendance lists
- Issued notifications
- Handled contracts
Oct 2012 - Jul 2013
10 monthsQuality Management Assistant
Med-X-Press GmbH
- CSV: validated entire corporate computer system per GAMP and other standards
- Managed compliance, NC/CAPA and risk
- Conducted root cause analyses
- Tracked and reported KPIs
- Reviewed QA documents
- Supported CAPA tracking
- Helped review logbooks and handle deviations
- Wrote, revised and implemented SOPs
- Took immediate corrective actions
- Ran QM measures and co-developed the integrated QM system per ISO 9001, GMP, GAMP, 2001/83/EC, EC 178/2002, ISO 17025, MPG
- Improved quality processes
- Trained on QM requirements and other quality topics
- Handled complaints (8D reports)
- Conducted risk analyses
- Ensured pharma product packaging met quality, timing, cost and resource requirements
- Managed deviations, complaints and OOS for packaging
Jul 2012 - Oct 2012
4 monthsMarketing, Sales and Project Management Assistant
Med-X-Press GmbH
- Attended and ran meetings, executed action items
- Coordinated and managed projects
- Shaped the ERP system with external developers
- Organized alignment processes inside and outside the company
- Reviewed and processed contracts for business and legal aspects
- Scheduled and organized meetings, documented and shared minutes
- Supported project leads with admin and org tasks
- Maintained and ensured data quality in project database; created and updated org charts and presentations; ensured formal correctness of project docs
- Distributed info and reported (project plans, status reports); made and updated effort and schedule plans and related reports; prepared steering committee materials
- Handled project controlling
- Collected, managed and checked timesheets
- Maintained resource overview (plan vs. actual)
- Monitored and updated project risk list
- Managed and tracked open-item list
- Kept attendance lists
- Issued notifications
- Handled contracts
Summary
Quality manager with leadership experience specializing in medical technology, pharmaceutical and chemical industries. I help pharmaceutical companies, medical device manufacturers, chemical companies and food companies meet regulatory requirements such as GxP, GLP, GDP, GMP, ISO 13485, ISO 9001, IFS, BRCGS, FSSC 22000, ISO 22000, IVDR 2017/746 and MDR. I also offer all professional and methodological skills to establish and develop quality management systems, process and project management, and as a Senior CSV Expert in validation projects as Validation Lead or Validation Coordinator.
Languages
German
Native
English
Advanced
French
Advanced
Spanish
Advanced
Education
Jan 1999 - Dec 2002
Private Heilpraktikerschule
Naturopath
Sep 1997 - Sep 1999
Inlingua Language School
Foreign Language Correspondent · English, French, Spanish
Apr 1989 - Mar 1990
Private Massage School of the Merciful Brothers
Masseuse and Medical Bath Therapist, Medical Foot Care Specialist
Certifications & licenses
Quality Management Representative Recertification incl. TQM ISO 9001:2015
Food QMB – Food Safety and Quality Representative
GMP Auditor (officially recognized)
GMP Expert
Quality Management Representative ISO 13485:2016
Lead Auditor in Quality Management IRCA
Trainer in Quality and Project Management incl. Project Leader
Quality Management Representative Certification incl. TQM ISO 9001:2008
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