Avertim Netherlands is currently looking for Medical Devices Process Engineers able to assist in the continuous expansion of Avertim’s consulting activities in Life Sciences & Chemicals. Located in Amsterdam-Zuid, Avertim Netherlands is a trusted partner by the largest players in the Life Sciences sector.Key responsibilities:Qualification & Validation of equipment related to Medical DevicesExperience with validation activities in a GMP environmentProcess design and continuous process improvement; make use of Lean and Six Sigma methodologies to identify areas for process improvement.Monitor process performance, identify bottlenecks, and initiate changesAbility to interpret data and to perform troubleshooting activitiesResponsible for keeping Standard Operating Procedures (SOP) and Work Instructions (WI) updated, so excellent technical writing (protocols, reports, standard operating procedures, transfer documentation, test methods) and good documentation practicesKeep Corrective and Preventive Actions (CAPA) actions, conduct Impact Assessments, and drive Change Controls as needed.Risk Management: Identify potential risks and develop mitigation strategies. Conduct root cause analysis for any issues and implement corrective actionsStakeholder management: work closely with cross-functional teams, Collaborate, support, and communicate efficiently with relevant team members.Your background:A Master’s Degree in Engineering, Pharmacy, Life Sciences or related field±3 years of working experience in the Life Sciences industry (pharmaceuticals, medical devices, biotechnology).Hands-on experience with Medical Devices (MDR/ISO 13485)Planning & organization – Planning & organization plans and organizes own work(load) in an effective way by setting priorities and meeting deadlines;Communicating & influencing – Communicates with clarity speaks and writes clearly and to the point; active listener;Proficiency in Lean and Six Sigma methodologies or Project ManagementFluent in English, Dutch is a plusResides in the NetherlandsDutch working permit, sponsorship not possibleAs an Avertimer, you will get the opportunity to:Immerse yourself into a young, vibrant, fast-growing team at our modern office, located in the Amsterdam business district, de ZuidasEnjoy our events, like team activities and afterworks.Develop yourself in a place where individuals and ideas matter, in line with our company values:Be yourselfTrust, ownership and respectListen and actWith offices in Brussels, Paris, Frankfurt and Amsterdam you will benefit from our international community. On top of that, we also support the opportunity to perform projects at multiple locations.Access various learning and development opportunities and an interesting career track. You will also receive a competitive compensation package in line with your experience.About Avertim:Avertim is a uniquely positioned Management Consulting Group that bridges the gap between Strategy and Operations. Our mission is to translate the strategy of our clients into actionable projects and enable the alignment between Business, Technology and Management. Founded in 2007, and headquartered on Brussels’ famous Louise Avenue, Avertim has grown into a European consultancy group with more than 300 consultants and offices in Belgium, France, Germany, and the Netherlands.Looking for a challenging and exciting new step in your career at a recognised international consultancy firm that works with the top players in the Life Sciences sector?Apply now!At Avertim, we value talent and mindset. No difference will be made during the recruitment process and applicants will receive consideration for employment whatever their gender, marital status, religion, age, color, sexual orientation, nationality or disability, …
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Medical Devices Process Engineer