Donovan Chie

Experience

• 

  Diemaster Industries

  Apr 2009 - Jun 2009

  Internship

  My responsibilities as an intern at Diemaster Inustries (RSA) included:- Learning and applying skills within a workshop (Filing, polishing, tapping, milling, welding etc.)- Assembling of plastic injection moulds and the handling of these

• 

  Pfisterer Sefag AG

  Sept 2012 - Feb 2013

  Internship

  My responsibilities as an intern at Pfisterer Sefag AG included:- Studying of subject-related products and norms- Various laboratory duties: Evaluation of mechanical properties of silicon, preparation of solutions / production of silicon rubber mixtures and their characterisation / performance in high voltage tests- Measurements in a testing institute abroad (Zittau, Germany)

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  ETH, Swiss Federal Institute of Technology, Zurich

  Nov 2014 - Dec 2015

  Research Assistant

  My responsibilities as a Research Assistant at the Particle Technology Laboratory included:- Designing, building and optimisation of a glove-box enclosed flame aerosol reactor- Designing, building and optimisation of a catalytic testing system- Production and synthesis optimisation of nano particles- Characterise particles with regard to size, morphology, crystallinity and surface chemistry- Development of thermogravimetric and chemical evaluation procedure for surface hydroxyl density- Preparation of two manuscripts for international journals and writing of a research proposal- Oral presentation at the 2014 Fall meeting of the Materials Research Society- Supervision of BSc and MSc Projects and Thesis- co-supervised a semester thesis on the computational description of zinc oxide nano particle growth- Supervision of semester project on doped zinc oxide for the use in gas detection.- Supervision of the filtration laboratory practical- Introduce students to safe laboratory practice, nano particle synthesis and characterisation, critical literature search, preparation of oral presentations and writing of scientific documents- Teaching assistant in the "Mass Transfer" lecture Show less

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  Biotronik AG

  Feb 2016 - Jun 2021

  • Ensuring regulatory requirements regarding cGMP, ISO 13485, 21 CFR part 820 and ISO 14971 risk management• Revision & optimization of standard processes, e.g. process risk management, process validation, non-conformity management and monitoring• Preparation and representation of the quality department in audits of notified bodies and authorities• Responsibility for the non-conformity management process (product-related deviations)• Management and support of CAPAs, including the coordination and moderation of root cause & risk analyses as well as defining measures and performing material usage decisions• Monitoring and trending of scrap data• Ensuring production capability and optimizing production processes• Creation, review and approval of validation protocols, reports and other documents related to the release of process and test methods • Supervision and management of up to three interns simultaneously• Management and implementation of extensive, complex & cross-departmental as well as cross-location projects, e.g.:- Transfer of production lines to the Singapore production site- Transfer of externally developed products and processes- Digitalization of scrap logging via SAP & mobile devices• Technical support and collaboration in projects, including:- Product & process development projects for CE and US markets- Quality improvement projects- (Re-) Certification projects according to MDD and MDR- Initial registration projects Show less • Ensuring regulatory requirements regarding cGMP, ISO 13485, 21 CFR part 820 and ISO 14971 risk management• Revision & optimization of standard processes, e.g. process risk management, process validation, non-conformity management and monitoring• Preparation and representation of the quality department in audits of notified bodies and authorities• Responsibility for the non-conformity management process (product-related deviations)• Management and support of CAPAs, including the coordination and moderation of root cause & risk analyses as well as defining measures and performing material usage decisions• Monitoring and trending of scrap data• Ensuring production capability and optimizing production processes• Creation, review and approval of validation protocols, reports and other documents related to the release of process and test methods • Supervision and management of up to three interns simultaneously• Management and implementation of extensive, complex & cross-departmental as well as cross-location projects, e.g.:- Transfer of production lines to the Singapore production site- Transfer of externally developed products and processes- Digitalization of scrap logging via SAP & mobile devices• Technical support and collaboration in projects, including:- Product & process development projects for CE and US markets- Quality improvement projects- (Re-) Certification projects according to MDD and MDR- Initial registration projects Show less - Ensures that the products, processes and projects at the Biotronik AG fulfill the technical requirements, cGMP guidelines and the quality management system specifications in the fields of development and production.- Represents the quality engineering department in the respective projects and production lines- Continually improves the product quality through optimizations of testing methods, as well as manufacturing and testing processes- Troubleshooting and non-conformity management (risk analysis, root cause analysis, corrective and preventive actions, product release, etc.) - Ensures and documents the technical quality of the manufactured products- Implementation, further development and support of manufacturing processes and product development (p-FMEA), process stability (validation and verification methods: EQ-POQ-PPQ) and quality (test planning).- Reviewer, author and moderator of process FMEAs and process validations- Planning, coordination and monitoring of test procedures during validations, as well processing and evaluating raw data, reporting and releasing processes / products- Setup and continually implementing manufacturing related test methods (including test method validation) and their status monitoring.- Trending, evaluation and reporting of quality relevant production data- International production line transfers, including verification, validation and release Show less - Ensures that the products, processes and projects at the Biotronik AG fulfill the technical requirements, cGMP guidelines and the quality management system specifications in the fields of development and production.- Represents the quality engineering department in the respective projects and production lines- Continually improves the product quality through optimizations of testing methods, as well as manufacturing and testing processes- Troubleshooting and non-conformity management (risk analysis, root cause analysis, corrective and preventive actions, product release, etc.) - Ensures and documents the technical quality of the manufactured products- Implementation, further development and support of manufacturing processes and product development (p-FMEA), process stability (validation and verification methods: EQ-POQ-PPQ) and quality (test planning).- Reviewer, author and moderator of process FMEAs and process validations- Planning, coordination and monitoring of test procedures during validations, as well processing and evaluating raw data, reporting and releasing processes / products- Setup and continually implementing manufacturing related test methods and their status monitoring.- Trending, evaluation and reporting of quality relevant production data Show less

  • Senior Manufacturing Engineer

    Dec 2020 - Jun 2021

  • Senior Six Sigma Specialist

    Apr 2020 - Nov 2020

  • Senior Quality Engineer

    Nov 2018 - Mar 2020

  • Quality Engineer

    Feb 2016 - Oct 2018
• 

  Congenius AG

  Jul 2021 - Jun 2024

  Consultant Operations

  Congenius offers tailored medical technology consultancy services in the fields of Quality, Regulatory, eHealth, Operations and Clinical. Our goal is to enable the smartest route to enhanced medical solutions by providing expertise and leadership to global firms, established SMEs and aspiring start-ups in the medical device, in vitro diagnostics and pharmaceutical industry.Personal Projects contracted via Congenius AG:- Product Quality Engineering in RMS Consumables department at Roche Diagnostics International AG (Jul. 2021 to present)Expertise and focus:• Regulatory requirements regarding cGMP, ISO 13485, 21 CFR part 820 and ISO 14971 risk management• Revision & optimization of company and production processes, e.g. process risk management, process validation, non-conformity management and monitoring• Management and support of CAPAs, including the coordination and moderation of root cause & risk analyses as well as defining measures and performing material usage decisions• FMEA Moderation• Monitoring and trending of production process parameters and product incl. digital implementation• Ensuring production capability and optimizing production processes• Creation, review and approval of validation protocols, reports and other documents related to the release of process and test methods • Supplier communication, management and development• Lean Six Sigma• Management and implementation of extensive, complex & cross-departmental as well as cross-location projects, e.g.:- Transfer of production lines- Transfer of externally developed products and processes- Digitalization of production and product monitoring• Technical support in:- Product & process development projects for CE and US markets- Quality improvement projects- (Re-) Certification projects according to MDD and MDR- Initial registration projects Show less

• 

  Roche Diagnostics International AG

  Jul 2024 - now

  People Lead to serve as the disciplinary and technical leader of a dedicated team of Operational Excellence Experts, fostering a culture of innovation, collaboration, and continuous improvement within the team, while driving strategic initiatives aligned with Global Operations objectives.Key ResponsibilitiesTeam Leadership:- Lead and manage a team of Operational Excellence Experts - Set goals, conduct performance reviews, and provide constructive feedback.- Foster a positive, collaborative, and innovative team environment.- Evaluate and develop employees through structured training and continuous education initiatives.- Build a strong community within the subchapter and across different Global Operations organisations, encourage networking.Resource Planning:- Plan and assign in collaboration with the Network Leads resources to projects and squads, understanding the unique strengths and skills of each team member.Technical Expertise:- Oversee the harmonisation, maintenance, and support of the Operational Excellence and Lean Tool Box.- Stay at the forefront of advancements in the area of expertise to guide the team effectively.- Manage and streamline all relevant business processes, ensuring consistent and efficient execution.- Promote the adoption of best practices in Operational Excellence and Lean.Stakeholder and Relationship Management:- Manage stakeholder relationships, particularly within OE Community- Build and maintain productive relationships with external providers.- Engage with product owners and digital translators to share and implement best practices.Budget & Resource Oversight:- Oversee the Subchapter’s budget, including planning and monitoring.Community Engagement:- Conduct training sessions and coaching to disseminate knowledge across the organisation. Show less Leadership and Strategy Development:- Ensure an environment that supports the development and implementation of strategic plans to achieve long-term objectives.- Analyze organizational and market trends so as to adapt strategies and maintain best in class.- Foster innovation and continuous improvement to drive organizational success.- Lead by example, promoting a culture of excellence and ethical leadership.Operational Excellence and Task Forces:- Spearhead task forces to address critical challenges and operational bottlenecks.- Streamline processes for increased efficiency, cost reduction, and productivity enhancement.- Implement best practices in operational management to align with overall business goals.- Use lean six sigma methods, analytical tools and simulations to drive optimizations.Coaching and Team Development:- Empower and develop team members through effective coaching and mentorship, particularly in areas of operational excellence and personal growth, so as to build a cohesive, high-performing team.- Promote a culture of continuous learning, knowledge sharing, and mutual support.- Elevate team morale and performance by recognizing and leveraging individual strengths.- Lead by example, demonstrating commitment to personal and professional development and inspiring the team to follow suit.Catalyst for Change and Innovation:- Enable digital transformation via supporting the implementation and use of digital tools in an operative environment, e.g. to increase process understanding & transparency and ensure process monitoring.- Enable and promote data driven decision making.- Serve as a catalyst and mediator, stimulating and accelerating organizational change and innovation.- Drive the adoption of state of the art methodologies and practices to continuously advancing the operational excellence maturity level of the organization and propelling it to the forefront of the industry. Show less

  • Subchapter Lead Operational Excellence

    Jan 2025 - now

  • Operational and Digital Excellence Manager

    Jul 2024 - Dec 2024