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Saskia Berkin is listed as Quality Engineering Manager at Smart Surgical Solutions, based in London, England, United Kingdom. AeroLeads shows a matched LinkedIn profile for Saskia Berkin.
Saskia Berkin previously worked as Business Director at Playmakers London and EU MDR Quality Engineering Manager at Smith & Nephew. Saskia Berkin holds Bachelor Of Science (Bsc), Biochemistry from University Of Leeds.
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Multi-functional experience particularly Global Manufacturing Operations, Quality Engineering, Regulatory Affairs.Leadership of complex projects with good track record of delivery.Expertise in quality systems requirements across wide range of functions, particularly change control and validation, including GxP document generation and approval.Technical knowledge and understanding of contract manufacturing and QA/RA environment of medical device, pharmaceutical and cosmetic wound management / prevention products, including ISO 13485, 21CFRs.Line management, including team objectives setting and development.
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London, England, United Kingdom
Smart Surgical Solutions (S3) is a MedTech spinout company from Imperial College London, developing the next generation of orthopaedic surgical navigation tools.- Build and implement the quality management system and relevant processes for the business, in accordance with regulatory requirements (ISO 13485, 21CFRs)- Conduct internal audits and maintain.
Founded an Arts Education Business.
Hull, United Kingdom
- Plan and execute R&D/Quality activities to support the remediation of the business product portfolio relative to the European Medical Device Regulations (MDR)- Co-ordinate with relevant global, regional and local teams, including external manufacturers to ensure adequate implementation, communication and training of the new business processes-Maintaining.
Kingston Upon Hull, England Metropolitan Area
- Identify operational improvements by collecting information, and generating insights and recommendations, including establishing new processes for future NPD project initiation taking into account the increased evidence, scrutiny and costs of gaining product registration under MDR legislation- Update existing R&D/Quality processes for the generation of.
Hull
- Managing a portfolio of external manufacturing change control projects driven by imperatives including cost saving, compliance and enforced material changes- Leading cross-functional project teams including global third party manufacturers (EU/US/China)- Compiling and reviewing technical documentation, ensuring work was compliant with the relevant.
- Co-ordinate with relevant global, regional and local teams to ensure adequate implementation of commercial projects- Conducting performance and analysis evaluations of competitor products- Delivering projects in accordance with agreed KPIs and benchmarks- Contributing to the continuous improvement of the analytical function with respect to new analytical.
Harrogate
- Operational support to the bioanalytics department including performing assays, assay transfers, validations, samples analysis, batch/release testing, and stability studies- Conducting all work in compliance with the applicable regulatory requirements (GLP/GCP/GMP) specified in the study plans, protocols, or client work agreements
Hull, United Kingdom
- Working with regional and global consumer insights & marketing teams to validate new ideas into the commercial pipeline- New product development including laboratory technical testing, validation, industrial trials and dossier preparation
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Saskia Berkin works for Smart Surgical Solutions.
Saskia Berkin is listed as Quality Engineering Manager at Smart Surgical Solutions.
Saskia Berkin is based in London, England, United Kingdom while working with Smart Surgical Solutions.
Saskia Berkin has worked for Smart Surgical Solutions, Playmakers London, Smith & Nephew, Smith+Nephew, and Rb.
You can use AeroLeads to view verified contact signals for Saskia Berkin at Smart Surgical Solutions, including work email, phone, and LinkedIn data when available.
Saskia Berkin holds Bachelor Of Science (Bsc), Biochemistry from University Of Leeds.
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