Technical product designer állások, munkák minőségbiztosítás kategóriában

Lead the implementation of quality systems and processes for the new facility, ensuring compliance with ​IATF 16949 and ​customer-specific standards (e.g., VDA 6.3, Formel Q, BMW QM-Requirements)....

The role combines two aspects: the Technical Support to Regions (TSR-API), which entails addressing any Regulatory Affairs and Quality Assurance needs that arise in the assigned region (EMEA), and the Technical Support to Manufacturers (TSM-API), which involves acting as the central point of...

You will be responsible for supporting the core and senior scientific leadership team by developing, maintaining, and executing programs and strategies across the business....

• Active contribution to Product care and a Key role in Product development as the technical lead for the Orbit & Consumables portfolio
• Technical support of product development project team

Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects...

Creation, editing, and review of all quality documents (DEV, CAPA, CCO, maintenance completion reports) in accordance with SOP specifications...

Write, review and approve design and development documents, including design inputs, outputs, verification, validation, and design transfer activities...

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

• Lead strategic relationships with CMOs to improve cost, quality, delivery performance and innovation (annual spend $60-70M)
• Conduct regular business reviews (SRM) and monitor KPIs, performance metrics, and contractual compliance

• Maintain and further develop our QMS in line with EN ISO 13485 and MDSAP
• Create, update, and improve procedures, forms, and training materials
• Plan and deliver training on procedures and regulatory requirements
• Lead and oversee CAPA initiation, processing, tracking, and review

• Create, edit, manage and modify all product and process documentation using PLM and ERP software packages.
• Be a part of the Manufacturing team with extensive interactions with the R&D and Quality departments.

Select and qualify packaging suppliers to ensure high-quality materials. Collaborate with suppliers to choose optimal packaging for Fresenius Kabi´s products....

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

Monitor and execute the data operations and data quality process. May include coordination of testing, error handling, data conversion and/or validation, and audit/compliance actions (Non-Conformance (NC) and/or Corrective Action Preventive Action (CAPA)). Provide tactical direction to third party...

Support the production manager in daily activities, ensuring business continuity and GMP compliance of production processes: mitigate technical and operational risks; lead weekly production planning execution; support shopfloor daily activities; when needed, coordinate and supervise production crew...

Define and lead the global Clinical Affairs strategy for Brainlab's global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teams...

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...

• 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