Marcel B. Email & Phone Number

Schweiz

RA and Q Consultant• As a Freelance RA and Q consultant, I managed various projects in the areas of development and maintenance of quality management systems ISO 13485:2016 to fulfil the requirements of MDR, IVDR and FDA 21 CFR PART 820 etc.• Interim management and consulting to support compliance with ISO 13485:2016 and FDA 21 CFR PART 820 requirements.• Consulting in the areas of packaging, sterile packaging and the corresponding international tests and validations.• Consulting in the areas of cleaning, cleanroom and its validation.• Treatment and consulting in the handling of complaints, CAPA and deviation management• Lead Auditor ISO13485:2016, 17025:2017• Consulting for the preparation of FDA inspection.• Support for ISO 13485:2016 certification.• Risk Management as per ISO 13485:2019; AAMI TIR 57:2016; ICE 60601,ICE 62304 such as autoinjector, infusion pumps and implants.• Supporting UEA to fulfill the requirements of a Safety Risk Analysis for a medical device.• Training of employees on ISO 13485:20216 and 21 CFR PART 820.

Metropolregion Lausanne

Role & Responsibilities• Lead Auditor ISO 13485:2016 and ISO 17025:2017.• I was responsible to organize and lead on boarding audit supplier audits, as well as sustaining audits.• Responsible for the correct processing of findings at the suppliers to ensure that Stryker's requirements were met by the supplier.

Metropolregion Lausanne

Supplier of PCB and IVD test equipment in the part of French Switzerland.Role & ResponsibilitiesAs Head of Quality Manager while reporting directly to the CEO, I had the responsibility for all quality-related activities at Valtronic Technologies (Suisse) SA, which included:o 6 Quality Engineerso Document Controllero 5 Quality control employeeso CAPA and Supplier Quality Engineer.• Update and maintaining the Q system to pass the ISO 13485:2016 certification.• Alignment of the Q-system with the new MDR 745/201 regulations.• Prepare the company to future FDA inspections, due to subscription to the FDA.• Leading costumer audit with the subject matter experts.• Leading the CAPA steering committee.• Administration of the Quality Engineering and Quality Assurance departments Document Control system, as well as technical files.• Supporting R&D to generate the Design History File (DHF).• Supporting the validation (Process, Sterilization, CSV and Medical Device Software).• Supporting to generate the Technical Documentation for submission and consult costumers in MDR and IVDR• Knowhow with IPC® 6xx standards and applications.• Implementation and validation of a PLM system.• Budget responsibility for their quality department.

Wohlen, Aargau, Schweiz

As Senior Quality Manager while reporting directly to the CEO, I had the responsibility to improve the quality system ISO 13485:2012, and as the company passed their ISO 13485-2016 certification and future FDA inspections. The company shall subscribe to the FDA register.Role & Responsibilities• Improve the quality system and train the employees on the new ISO 13485-2016 and 21CFR 820.• Convert the Quality System from ISO 13485:2012 to ISO 13485:2016.• Perform gap analyses and improve the SOP’s and work instruction.• Risk management and risk analysis aliened to the EN ISO 14971:2013.• Perform gap analyses of the technical documentation and complete the documentation with missing information or improve insufficient documents.• Manage the validation of the water processing / treatment and the cleaning validation of the parts which are to be transferred to the cleanroom.• Manage the validation of the clean room, cleaning and packaging equipment’s (pouch and blister).• Manage the packaging qualification and validation of medical devices as per ISO 11607-1 and ISO 11607-2.• Organized by an external supplier, the validation of EO and Gamma sterilization.• Actively connecting people from other cultures.• Coordinator of new DS-GOV (GDPR; General Data Protection Regulations) which became a law on Mai 25th, 2018.

Bern, Schweiz

Private owned Group with 4 sites of cross-national environments which are located in: Switzerland, Hungary and the Netherlands. The company has a global workforce of around 750 employees. The company delivers primary packaging to the pharmaceutical and medical device industries.Role & Responsibilities• Improve the quality system and train the employees on the new ISO 13485-2016 and 21CFR 820.• Convert the Quality System from ISO 13485:2012 to ISO 13485:2016.• Perform gap analyses and improve the SOP’s and work instructions.• Risk management and risk analysis aliened to the EN ISO 14971:2013.• Perform gap analyses of the technical documentation and complete the documentation with missing information or improve insufficient documents.• Manage the validation of the water processing / treatment and the cleaning validation of the parts which are to be transferred to the cleanroom.• Manage the validation of the clean room, cleaning and packaging equipment’s (pouch and blister).• Manage the packaging qualification and validation of medical devices as per ISO 11607-1 and ISO 11607-2.• Organized by an external supplier, the validation of EO and Gamma sterilization.• Actively connecting people from other cultures.• Coordinator of new DS-GOV (GDPR; General Data Protection Regulations) which became a law on Mai 25th, 2018.

Schweiz

Role & ResponsibilitiesAppointed as project leader for Europe’s “Production and Process Control” work stream to remediate the QMS Europe.• Main areas are Acceptance Activities and Facility and Equipment Control.• Prepare the QMS Europe for the integration into a new QMS for GMP/FDA/ISO requirements, to ensure that Europe will meet current regulatory and future expectations.• To create and maintain relationships that empowers the business unit to follow the future QMS.• Managing 13 consultants technical, scientific and managerial consultants to reach the remediation objectives.• Assumed a role of a coordinator, between the US and Europe.• Responsibility for leading the introduction of statistical production control software in Europe: Q-DAS.• Trainer of Patient Centric Structured Problem Solving.

Schweiz

Role & responsibilitiesQuality and Process Manager while reporting to the Director of Quality Assurance Europe. Member of a plant management team and management representative I had the responsibility for all quality activities at the site, which included:• Implementing the Quality System including CFR 21 PART 820 and ISO 13485.• Leading the FDA inspection (Front Room).• Leading Notified Body audits (Front Room).• Key responsibilities included managing and maintaining the Quality System and leading of 25 employees of the quality department at site.• Management of quality inspectors.• Management of Packaging employees.• Administration of the Quality Engineering and Quality Assurance departments Document Control system.• Managing the team of quality and validation engineers, document controller and quality inspectors for First Article Inspection and Incoming Inspection.• CAPA Coordinator.• Coordinated validation activities for site.• Supported process development and optimization for operation, engineering and maintenance.Extensive experience in introducing and managing quality assurance systems to align with CFR 21 PART 820 and 13485 that includes packaging, sterilization and validation. Strong development and management experience of clean room technologies including validation and monitoring of sterile products. Solid business management experience and leading FDA inspections.