Quality control r supervisor

Cerchiamo per strutturata azienda cliente operante nel settore automotive una figura da inserire come QUALITY PLANT MANAGER. La figura, riportando al Managing Director, si occuperà di: •gestire e coordinare il Sistema Qualità (in collaborazione con l'Uff. Gestione Sistemi) al fine di un’efficace gestione per la qualità nella logica del miglioramento continuo; •collaborare alla verifica costante del Sistema Qualità per mezzo di audit interni (di responsabilità dell’Uff. Gestione Sistemi che potrà comunque avvalersi di personale qualificato di Plant); •mantenere il controllo della pianificazione delle conseguenti azioni correttive / di miglioramento; •collaborare con l’Uff. Gestione Sistemi per soddisfare alle richieste informative dei clienti sul Sistema Qualità; •definire e gestire il sistema di raccolta dati funzionale sia per esigenze specifiche di Plant sia per realizzare il monitoraggio di indicatori definiti a livello di gruppo; •elaborare statistiche e report sulle attività della funzione; •definire e gestire il sistema di raccolta dati funzionale ai riesami di sistema; •preparare e gestire visite valutative esterne (da parte di Clienti ed Enti di Valutazione) concordando l'eventuale supporto del R.G.S. e dell’Uff. Gestione Sistemi; •presiedere (anche tramite la collaborazione dell’Operatore del Quality Control) le attività produttive dal punto di vista della qualità del prodotto e del processo interagendo con tecnologo ed operation per un’ottimizzazione della gestione dei reparti; •promuovere, concordare ed attuare piani di miglioramento per perseguire gli obiettivi di qualità dei reparti di competenza; •partecipare alla validazione di attrezzature per i reparti di competenza; •coordinare l’attività del Quality Wall; •gestire situazioni di non conformità (interne / resi / in accettazione per il proprio sito) anche nella risposta al cliente, assicurando corretta registrazione nella base dati aziendale ed a

Supplier Quality Engineer Important international company of healthcare. The Supplier Quality Engineer (SQE) ensures that the supply chain companies (suppliers) continually develop their process in line with the design intent of the customer and verify their systems to ensure they are compliant with the end customer's needs. This includes on-going supplier verification. The SQE is responsible for delivering all aspects of the Supplier Quality Assurance function.He/ She collects root cause analysis and provide corrective feedback to prevent line stops due to supply issues. Establish incoming inspection plans for components with the supplier & R&D department, assemblies and/or finished devices and quality department Ensure the proper risk controls are implemented at both supplier and the company, the measurement system at supplier & the company are identical, and/or capable, Monitore and analyze supplier data internally and externally gathered to identify trends and prevent potential problems Initiate and manage Supplier Corrective Actions (SCAR, SAR) in partnership with Manufacturing/Process Engineering and Quality Engineering to ensure complete and effective root cause analysis and corrective action implementation is performed promptly Use appropriate methods such as Statistical Process Control (SPC), Advanced Quality Process (AQP) tools and the metrics, proactively to identify and help implement improvement to supplier quality and supplier quality tools and processes Collaborate with other members of the supply team to establish and maintain a meaningful supplier quality scorecard. Permanent position. Inserzionista: Page Personnel

Functieomschrijving Randstad Hr Solutions, part of Randstad Group, focused on HR consulting services, for Thermo Fisher Scientific is looking for a Team Leader – Sterile Area Responsabilità The Team Leader - Sterile Area, reporting to the Sterile Department Supervisor, is responsible for planning and managing production activities during shifts, ensuring adherence to all regulatory control and documentation procedures, according to schedule, cost and quality standards. The selected person will have the chance to prove his/her leadership skills in a highly dynamic and result-driven environment. Key tasks: ? Overseeing operatives in day to day operations, making sure that production schedule, Right First Time and On Time Delivery KPIs are met; ? Managing anomalies and deviations, solving production problems with the support of the department head ? Ensure high standards of safety and engagement amongst his team/shift; ? Support the Sterile Department Lead in making sure that the Sterile production operations are properly controlled and regulatory compliance requirements are met by guaranteeing batch documentation is accurate, Standard Operating Procedures are accurate, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility  Functie-eisen Qualifications: ? Degree’s in CTF, Chemistry, Biology or other similar fields; ? Good communication and leadership skills; ? Able to organize activities and resources and to recognize problems developing, not just occurring; ? At least 1 year of experience in GMP production environment; ? Experience with aseptic process;  Available to work on shifts

The Process Engineering Specialist brings operations-expertise to help the organization in order to optimize production processes and realize substantial efficiency and cost saving. Act as a strategic partner, providing value-added solutions, developing and implementing hands-on measures in order to realize the required process improvements and ultimately improve margins; Drive changes and efficiencies by recommending new ways to operate, contributing actively to their actual implementation and providing feedbacks; Build realistic and comprehensive action plans to reduce cost, increase quality and improve service level; Participate at meetings with Automation department in order to define the technical requirement specifications for new equipments considering R&D, QA and Operations requests; Define, execute and validate the production process of new product in collaboration with R&D; Define, write and update production manual (MOP) and guarantee the quality for the entire process; Transfer production process; Execute process changes related to: methods, parameters and material changes; Execute Operational Qualification (OQ) and Performance Qualification (PQ); Execute equipment and production validation using statistical tools such us Gage R&R, Capability analysis, DOE, Regression, Hypothesis tests and others. Promote process improvements using Lean Six Sigma Approach.Medical DevicesGreat growth opportunityGood English level (B1 Level) Management of the validation documents necessary for the process control and improvement and deep knowledge of validation strategy (IQ - OQ - PQ); Knowledge and experience with statistical tools: DOE study, Gage R&R, Capability analysis (Cp, Cpk, Pp, Ppk), sampling size definition preferably by means Minitab sw. Green Belt Certification will be a plus Degree in Engineering At least 4-5 years of experience holding position in process engineering dept.Multinational Company leader in medical devicesGreat growth opportunity

Act as a strategic partner, providing value-added solutions, developing and implementing hands-on measures in order to realize the required process improvements and ultimately improve margins; Drive changes and efficiencies by recommending new ways to operate, contributing actively to their actual implementation and providing feedbacks; Build realistic and comprehensive action plans to reduce cost, increase quality and improve service level; Participate at meetings with Automation department in order to define the technical requirement specifications for new equipments considering R&D, QA and Operations requests; Define, execute and validate the production process of new product in collaboration with R&D; Define, write and update production manual (MOP) and guarantee the quality for the entire process; Transfer production process; Execute process changes related to: methods, parameters and material changes; Execute Operational Qualification (OQ) and Performance Qualification (PQ); Execute equipment and production validation using statistical tools such us Gage R&R, Capability analysis, DOE, Regression, Hypothesis tests and others. Promote process improvements using Lean Six Sigma Approach.Multinational Company leader in medical devicesGreat Growth OpportunityGood English level (B1 Level) Management of the validation documents necessary for the process control and improvement and deep knowledge of validation strategy (IQ - OQ - PQ); Knowledge and experience with statistical tools: DOE study, Gage R&R, Capability analysis (Cp, Cpk, Pp, Ppk), sampling size definition preferably by means Minitab sw. Degree in Engineering Green Belt Certification will be a plusAt least 2-3 years of experience holding position in process engineering dept.Multinational Company leader in medical devicesGreath Growth Opportunity