Principal Supplier Quality Engineer

☞ SEC Life Sciences

Visualizza: 167

Giorno di aggiornamento: 22-10-2024

Località: Heidelberg Baden-Württemberg

Categoria: Garanzia di qualità / Controllo di qualità

Industria: Medical Equipment Manufacturing

Posizione: Mid-Senior level

Tipo di lavoro: Full-time

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Contenuto del lavoro

Principal Supplier Quality Engineer - Medical Devices

This position will be joining a well-established world-class external QA team covering the EMEA region for a global life sciences company, working in sterile, non-sterile pharma and medical device manufacturing. The position requires an expert in medical device manufacturing, who can oversee a large network of external manufacturing partners (CMOs) across Europe. You will provide expertise to ensure the best products are being produced for the company to provide to customers across the world.

Role and responsibilities:

*Evaluate, develop and support the quality level of external manufacturers across Europe
*Control compliance activity with external manufacturers - overseeing their Quality Assurance operations
*Maintain a robust manufacturing process at all external partners, including risk management and root cause analysis
*Provide guidance and QA consultation during new product development, technical transfers and product launches
*Support continuous improvement across the CMO network
*Participate in supplier and external audits according to GMP standards
*Manage QA related documentation including customer complaints, CAPAs, Non-Conformances and Deviations

Requires skills and qualifications:

*Master’s Degree or PhD in a scientific or related discipline
*7+ years’ experience in pharmaceutical manufacturing environments
*Deep knowledge of working with external manufacturers and QA - especially within medical devices
*Excellent working knowledge of EU MDR and ISO13485 regulations
*Thorough knowledge and experience in GMP
*Fluency in English, spoken and written
*Flexibility to travel up to 30% of the time, throughout Europe

This position can offer a hybrid remote/on-site flexibility and joins a team of experts with an excellent network of CMOs producing best-in-class surgical products. You will play a key role in managing this process and ensuring thousands of patients receive the best treatments available to them, whilst developing your career within QA.

To apply for this position and put yourself under immediate consideration, send your CV to john.spring@seclifesciences.com or call +44 (0) 207 255 6650

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Scadenza: 06-12-2024

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