Minőségbiztosítási munkatárs állások, munkák Külföldön

• Űripari projektek minőségbiztosítási támogatása a fejlesztési és sorozatgyártási szakaszban
• Minőségbiztosítási dokumentumok elkészítése és egyeztetése az ügyféllel
• Specifikációk és vizsgálati eredmények értékelése és jóváhagyása
• Első darab vizsgálatok (FAI) elvégzése

• Fémes minták szakítóvizsgálata Zwick gépeken
• Romboló anyagvizsgálatok elvégzése laboratóriumi környezetben
• Vizsgálatok dokumentálása, jegyzőkönyvek készítése
• Munkavégzés szabványok és eljárási utasítások szerint

PURPOSE - The purpose of the role is to represent the Quality department in transport projects by: - Guaranteeing methodological rigor in the development plan and coordinating all qualities activities within the project teams.   TASKS AND RESPONSABILITIES - Ensure that development standards are...

• Strategic quality assurance, review of Q requirements and auditing of suppliers
• Carrying out internal product tests and inspections
• Responsibility and assurance of delivery quality
• Evaluation, monitoring and situational development of existing and potential new suppliers

Following up on production-related nonconformities, supporting root cause analyses, defining and monitoring corrective actions, and preparing evaluations and statistics of nonconformities...

• Guiding and supporting your team by overcoming roadblocks and exceeding expectations
• Ensuring appropriate staffing for all active Simultaneous Development Teams (SDTs) in collaboration with Program Management and Quality leadership

• Planning and initiation of business cases, definition of the project scope, objectives and deliverables. This includes gathering requirements, assessing feasibility and developing a project plan that aligns with organizational goals
• Monitoring of timelines and budget

• Maintaining and continuous improvement of the Quality System, including the associated management documentation and ISO certifications
• Planning and coordination of internal audits as per Internal Audit Plan
• Planning and coordination of the yearly Management Reviews including Reporting

Prepare, support the creation and review and execute the release of all technical documentation for digital health and software products ensuring compliance with applicable standards and regulatory requirements such as IEC, IEC...

• Take part in the definition of quality objectives for suppliers and supplier management
• Conduct quality audits at suppliers and service providers
• Support Purchasing in supplier selection.

• Conducting and scheduling internal and external system and process audits (ISO 9001,, and, as well as IATF), including customer audits
• Evaluating and maintaining data for the environmental management system
• Tracking of CIP, measures from audits and their effectiveness

• Acting as a key contact to IEE customers for quality-relevant topics during development and serial production
• Handling customer complaints
• Organizing and following up of customer audits
• Minimizing quality risks
• Preventing field actions
• Minimizing warranty costs and scrap costs

• Developing and maintaining sterility assurance and contamination control strategies for aseptic processing
• Leading risk assessments for aseptic process, single use systems and critical interventions, and ensuring compliance with authorities relevant Guidance such as Annex 1

• In-process controls, release and stability tests using HPLC-based analytical methods 
• DLS-based analyses; pH, IR, and wet chemical analyses
• Visual appearance test of finished drug product for batch release and stability 

• Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary.
• Directly reports to include quality control supervisors.

• Implement and maintain quality procedures in accordance with ISO
• Lead or support internal audits.
• Manage and drive the internal non-conformities process until issues resolutions.
• Manage Non conform product segregation and containment actions.

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

• Professional management of the Global Account / Key Account Product Quality Engineers
• Responsible for qualitative products in the market and supporting customer quality expectations and requirements
• Responsible for quality escalations or customer dissatisfaction regarding quality progress

• Establish the project quality plan for each project phase, to meet the project requirements and expectations.
• Implement and manage quality management tools and activities.
• Provide quality input to strategies and procedures.

• Qualification and further development of suppliers
• Supplier and process auditing
• Responsible for the implementation and scheduling of the necessary internal and external audits