Junior designer állások, munkák minőségbiztosítás kategóriában

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...

• Working with high throughput lab – analyzer
• Routine lab work with infectious samples and leading of own experiments including the analysis of them
• Plan and execute different work packages for the development of molecular diagnostics test

• Play an important role within in a multidisciplinary team in the development of new and complex products / segments / features and in the management throughout the entire life cycle
• Create product visions and/or strategies independently for complex products / segments / features

• Drive innovation by evaluating and continuously advancing therapies through aerosol inhalation
• Communicate scientific insights effectively and foster strong interdisciplinary collaborations to ensure successful translation into clinical practice

• Ensuring EPR compliance (WEEE, VerpackG, BattG) for Leica Microsystems, including registration and reporting in relevant markets. • Responsibility for action plans and coordination of cross-functional activities (e.g. workshops, Kaizens, daily management). • Guiding of departments in implementing...

• Driving supplier performance improvement through root cause analysis, corrective action and supplier performance reviews;
• Ensure compliance with the European Medical Device Directive and associated regulations;

You will be a part of the Field Applications Specialist Team and report to the Field Application Manager responsible for providing frontline support by resolving customer(s) problems and issues through technical, scientific expertise and troubleshooting. You will help drive revenue growth while...

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

• Scientific lead and coordination of Critical Quality Attributes (CQA) evaluations and product characterization studies
• Representation of Analytical Science in the customer project teams, coordination of activities and implementation of the QbD strategy

• Develop clinical trial strategies, shaping study designs based on regulatory requirements, competitive insights and company's research interest.
• Give insights into clinical data sets and evidence for our company's products to internal stakeholders.

Execution of consulting projects with a focus on developing market access and dossier strategies, including preparation of corresponding workshops, and participation in oral hearings with relevant authorities...

• Lead the commercial development of profitable lab testing services
• Lead and develop the lab organization
• Monitoring of the laboratory and all work carried out there, to ensure compliance with relevant internal procedures and regulations

• Drive and complete reimbursement applications for the Vibrant product portfolio
• Build and check health economic models that clearly demonstrate product value by using appropriate software tools

• Lead and develop the Product Risk Management team
• Own and continuously improve the risk management process according to ISOwithin our product development framework
• Ensure high-quality risk analyses and maintain consistent, audit-ready risk management documentation

Independent realisation of production processes: Responsible execution of filtrations and chromatographic applications in production scale (250 to 1000 litres), according to the specifications for the GMP environment...

• Collaborate with cross-functional teams including IT, Quality Assurance, and Operations to ensure documentation and validation of systems according to internal procedures
• Ensure compliance with internal and external regulatory requirements and guidelines
• Maintain the inventory of software applications

• An agile career and dynamic working culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance
• Along with competitive salaries, you’ll find a wide range of lifestyle, family and leisure benefits available.

In your new role, you will define and implement the global strategy for analytical development, supporting BI's pipeline from early research through candidate characterization and selection to drug product development and launch....

QMS Process Management: Oversee the full lifecycle of changes for PTT owned QMS documents, from change initiation and action item assignment to responsible owners across the global network, driving completion and secure the final "approval to execute" before documentation is made effective...

• Responsible for performing laboratory-based activities and processes
• Tracking, inventory, sample processing, and transport of biological samples from clinical and non-clinical trials
• Manage associated metadata, and ensuring that lab activities fulfill customer needs