Lead operator 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)....

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

Deliver technical expertise in the development of container closure systems, including vials, prefilled syringes, and prefilled cartridges, by employing cutting-edge methodologies to conduct comprehensive analyses and evaluations of their protection, safety, compatibility, and performance attributes...

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

• 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

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

• 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

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

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...

• 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

• 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

• 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

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

• 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

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

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...

• 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.

• Coordinate alliance management activities and ensure adherence to contractual commitments
• Support (and later) lead contract-related updates, including tracking and initiating required changes
• Contribute to achieving key alliance business objectives

• 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

• Operate as the primary point of contact taking comprehensive care of the needs of our customers around the world
• Ensure premium customer care through regular, remote and on-site Business Review Meetings (BRM) as well as leading Weekly Business Meetings (WBM)