Brussels Region, Belgium
Responsible for developing, implementing, and sustaining Quality operations and Compliance processes. This role focuses on leading Quality Engineering initiatives related to surgical console refurbishment and reprocessing. Key responsibilities: •Ensuring Quality Assurance and Compliance for the Global Technical Service activities in the Bornem Plant •Manages quality team responsible for quality operations of Technical Service Product Refurbishment, Reprocessing and Calibration •Quality lead on commissioning projects related to implementation of new refurbishment processes and infrastructure at the plant •Responsible for operations of local tool calibration program needed to service local field and refurbishment operations •Implements and operationalizes Alcon’s Quality Assurance programs, policies, processes, procedures and controls; ensuring that performance and quality of products conform to establish standards and agency guidelines to ensure lasting customer satisfaction •Leads quality monitoring and improvement initiatives for the Refurbishment & Calibration activities at site •Acts as quality liaison when interfacing with other repair centers or field associates •Leads and manages relevant non-conformance investigation and CAPA management from investigation to closure. Collaborates with staff to ensure proper and timely resolution of issues. •Develops standard tools and processes to enable and support high quality service delivery and improvement •Provides support as subject matter expert for internal audits and external audits and inspections •Maintains expertise in Alcon Surgical Equipment and processes and advocates for the quality and compliance requirements and needs •Establishes and ensures compliance to quality processes and procedures by coordinating with Quality, MTO and Engineering •Interfaces between Alcon and the various governmental agencies
Custom Pack Production: • Supplier & Component management • Performing internal and supplier audits on behalf of Alcon • Supporting external audits & inspections • Validation of systems & equipment and associated risk management • Bioburden & environmental monitoring & pest control • Coordination and execution of CAPA’s, change controls and non-conformance investigations • Review of external and corporate standards (cGMP, ISO 13485, MDD, MDR) • Data integrity & e-Compliance SME • QA oversight of maintenance & calibration, QMS document management and training • Quality metrics reporting • Procedure & process enhancement and studies (packaging integrity, stability & transportation study)
Formulation department of Covid Vx: - Quality deviation handling (DMAIC root cause analysis and CAPA definition) - Quality ‘point of contact’ within the formulation department - Defining and following Quality KPI’s within formulation department - Giving training to Production Engineers, Supervisors, Operators,… - Writing and updating standard operating procedures - Supporting external/internal audits
Secondment for reducing the backlog of overdue non conformances within production department.
Packaging department: - Quality deviation handling (Impact assessment, NTM, FAR,…) - Daily support to production department - Writing APR’s and QPR’s - Impact assessment of market temperature excursions and local reworks - Writing and updating SOP’s, WI’s and FORM’s
Alkane biofuels biosynthesis in collaboration with Toyota Motor Corporation • Screening of alkane producing micro-organisms using pulp as a substrate • Optimising enzyme activity of medium-chain alkane producing bacteria from aldehydes • Development of host vector system for FFA accumulating fungus Basidiobolus Meristosporus for the production of bioalkanes