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🔍 What makes a great Quality Engineer in Medical Devices? In the fast-paced world of medical devices, a Quality Engineer plays a pivotal role. But what sets the best apart? Here are some top qualities: ✅ **Attention to Detail**: The smallest oversight can have significant consequences. A great Quality Engineer meticulously reviews every aspect, ensuring nothing is overlooked. ✅ **Problem-Solving Skills**: Challenges are inevitable. The ability to quickly identify issues and develop effective solutions is crucial. ✅ **Strong Communication**: Whether it's liaising with team members or reporting to stakeholders, clear and concise communication is key. ✅ **Regulatory Knowledge**: Understanding and staying updated with industry regulations ensures compliance and smooth operations. ✅ **Analytical Thinking**: Data-driven decisions are essential. A great Quality Engineer analyses data to drive improvements and ensure product quality. These qualities not only ensure the highest standards but also drive innovation and efficiency in the medical devices sector. What qualities do you think are essential for a Quality Engineer? Share your thoughts below! #QualityEngineering #MedicalDevices #Recruitment
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Clarifying Quality Roles in the Medical Device Industry I often get asked about the different quality roles in the medical device world, and I thought it might be helpful to share some definitions and responsibilities from my experience. Each role plays a crucial part in ensuring that medical devices are safe, effective, and compliant. Here’s a quick rundown: 🔧 Test Engineers Responsible for validating that medical devices meet design requirements and function safely. This includes roles like: 1. Software Test Engineers (SQA): Verifying software against functional and cybersecurity requirements as part of regulatory compliance. 2. Hardware Test Engineers: Ensuring physical components meet specifications through rigorous testing. 3. System Test Engineers: Focusing on hardware and software integration to verify system performance. 4. Validation Engineers: Ensuring tools and methods used in Verification & Validation (V&V) activities are qualified and reliable. 5. Clinical Engineers: Handling formal validation and testing devices in clinical environments. 🛠️ Manufacturing (MFG) Test Engineers Focused on testing and validating manufacturing processes before full-scale production to ensure consistency and quality. This includes: 1. Process Test Engineers: Conducting Process Performance Qualification (PPQ) and optimizing manufacturing steps. 2. Quality Control (QC): Managing In-Process Quality Control (IPQC) and Outgoing Quality Control (OQC) to ensure products meet standards. 3. Supplier Quality: Overseeing Incoming Quality Control (IQC) for materials from third-party suppliers. 🔍 Quality Assurance (QA) Ensuring compliance with standards and regulations, reviewing the Design History File (DHF) to maintain quality and reduce auditing risks. 📜 Regulatory Affairs (RA) Managing regulatory compliance, ensuring products meet regional and international standards (e.g., FDA, EMA). 📈 Customer Service Representatives (CSR) Monitoring device performance after market release, handling customer complaints, and ensuring feedback is addressed. This is my understanding of these roles, but I’d love to hear from you! Let me know if I missed anything or if you have any thoughts to share! See the details in the attached for more in-depth information. #MedicalDevices #QualityAssurance #TestEngineering #RegulatoryAffairs #Manufacturing #CustomerService #HealthcareInnovation #Compliance
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Hello #Connections We are hiring #MDR-Regulatory Affairs Specialist - Hybrid but open to remote for the right consultants. Note : Open only for W2 𝐓𝐨𝐩 3 𝐒𝐤𝐢𝐥𝐥𝐬 : Detail-oriented for review of product changes and documentation review, including labeling. Prior experience authoring EU MDR Technical documentation and managing review with notified body. Experience routing documents and changes through a controlled document control system. 𝐄𝐝𝐮𝐜𝐚𝐭𝐢𝐨𝐧 𝐑𝐞𝐪𝐮𝐢𝐫𝐞𝐝 : Bachelors in a scientific or technical discipline, engineering is preferred. Minimum of 3 years with advanced degree and Minimum of 5 years with a bachelor’s degree #eumdr #technicaldocumentation #labeling #documentation #regulatoryaffairs #controlsystem
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Validation Lead (QEA) | GAMP5 GxP 21 CFR Part 11 QSR 820 IQ OQ PQ, CAPA | Computer System Validation
✅Top 5 Best Practices for Validation Leads in Quality Engineering As a Validation Lead in Quality Engineering, ensuring consistent quality and regulatory compliance is paramount. Here are five best practices to elevate your validation processes: 🔧Risk-Based Approach: Prioritize validation efforts based on risk assessment. Focus on critical systems and processes that directly impact product quality and patient safety. 🔧Comprehensive Documentation: Maintain detailed, clear, and traceable documentation throughout the validation lifecycle. This includes requirements, test plans, protocols, and final reports. 🔧Automated Testing: Implement automated testing where possible to improve efficiency, reduce human error, and enable consistent, repeatable validation processes. 🔧Continuous Monitoring: Establish ongoing monitoring systems to ensure validated states are maintained. Implement change control processes to manage updates and modifications. 🔧Cross-Functional Collaboration: Foster strong partnerships with development, operations, and regulatory teams. This ensures alignment on validation strategies and helps anticipate potential compliance issues. By following these practices, Validation Leads can significantly enhance quality assurance and maintain regulatory compliance in their organizations. What other validation best practices have you found effective in your role? Share your thoughts in the comments! #Validation #QualityControl #QualityEngineering #ValidationBestPractices #RegulatoryCompliance #QualityAssurance
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Do your projects need technical expertise to help drive results? Could you use additional bandwidth to execute pending project milestones? Let's connect to see how we can support your project needs! 🤝 #medtech #consulting #engineering #capacity #medicaldevice #regulatory #quality #projectmanagement
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🔍 Top 3 Skills Required for Quality Engineer Job in Medical Device Industry 🔍 Are you aiming for a career as a Quality Engineer in the dynamic and impactful Medical Device industry? Here are the top 3 skills you need to succeed: 1. Regulatory Knowledge 📜 Understanding FDA, ISO 13485, and other regulatory requirements is crucial. Staying updated with compliance standards ensures the safety and efficacy of medical devices. 2. Analytical Skills 🔍 Strong problem-solving abilities and proficiency in data analysis are essential. These skills help in identifying potential issues and implementing effective solutions to maintain quality. 3. Attention to Detail 🧐 Precision and thoroughness are key. A meticulous approach ensures that every aspect of the device meets high-quality standards, reducing the risk of defects and enhancing patient safety. Develop these skills to excel and make a meaningful impact in the Medical Device industry! #Hiring #Medicaldevice #QualityEngineer #GroveTechnicalResources
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Are you a MedTech leader that could use a trusted partner to drive projects to the finish line? Let's connect! 👊 #MedTech #consulting #engineering #capacity #medicaldevice #regulatory #quality #projectmanagement
Do your projects need technical expertise to help drive results? Could you use additional bandwidth to execute pending project milestones? Let's connect to see how we can support your project needs! 🤝 #medtech #consulting #engineering #capacity #medicaldevice #regulatory #quality #projectmanagement
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𝗤𝘂𝗮𝗹𝗶𝘁𝘆, 𝗮 𝗴𝗿𝗼𝘄𝗶𝗻𝗴 𝗱𝗲𝗺𝗮𝗻𝗱. Quality is essential in the #lifescience industry. It’s quintessential to the safety, compliance, structure, and credibility of any business operating ! Therefore best talent in quality is in consistent demand, which can make finding the perfect candidate exceptionally tricky. That' why we're here to help. Our team is made up of life science experts with a passion for people. As market passionate professionals, we understand your industry needs better than average recruitment agencies. Our extensive international talent network allows us to identify and match the best quality professionals with the ideal opportunities. Our community network is consistently updated, and our connections are cherry picked to ensure that our clients benefit from the leading talent on the market. 𝗖𝗿𝘂𝗰𝗶𝗮𝗹 𝗶𝗺𝗽𝗮𝗰𝘁. Every aspect of the quality division contributes towards a safer and more efficient future in the life sciences. A comprehensive quality management function enables the innovation that meets tomorrow’s medical needs. For businesses in the life sciences, growth is much more than just making profit – it’s about bringing meaningful and positive change to the world as we know it, and quality is instilled at the heart of this transformation change. Adhering to the highest level of quality not only prevents life-threatening defects from occurring in a product or devices, but it streamlines processes for compliance and efficiency, boosting the bottom line. It’s a win-win when you find the right talent. Typical Roles and Responsibilities in 𝗧𝗲𝗰𝗵𝗢𝗽𝘀 𝗤𝘂𝗮𝗹𝗶𝘁𝘆: · QA/QC Engineers · Quality Manager / Director / VP · Quality Analyst/Officer · Quality Compliance/Vendor/Supply Chain · GMP/GxP/GDP expert · Lean Expert · Process Excellence Expert · Downstream/Upstream · Project Manager · Manufacturing / Production Engineers Let's discuss our unique approach to #talentattraction, that we successfully deployed to niche industries. Book a call for further insights : shorturl.at/aeCRX #hiring #biopharma #careergrowth
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𝗤𝘂𝗮𝗹𝗶𝘁𝘆, 𝗮 𝗴𝗿𝗼𝘄𝗶𝗻𝗴 𝗱𝗲𝗺𝗮𝗻𝗱. Quality is essential in the #lifescience industry. It’s quintessential to the safety, compliance, structure, and credibility of any business operating ! Therefore best talent in quality is in consistent demand, which can make finding the perfect candidate exceptionally tricky. That' why we're here to help. Our team is made up of life science experts with a passion for people. As market passionate professionals, we understand your industry needs better than average recruitment agencies. Our extensive international talent network allows us to identify and match the best quality professionals with the ideal opportunities. Our community network is consistently updated, and our connections are cherry picked to ensure that our clients benefit from the leading talent on the market. 𝗖𝗿𝘂𝗰𝗶𝗮𝗹 𝗶𝗺𝗽𝗮𝗰𝘁. Every aspect of the quality division contributes towards a safer and more efficient future in the life sciences. A comprehensive quality management function enables the innovation that meets tomorrow’s medical needs. For businesses in the life sciences, growth is much more than just making profit – it’s about bringing meaningful and positive change to the world as we know it, and quality is instilled at the heart of this transformation change. Adhering to the highest level of quality not only prevents life-threatening defects from occurring in a product or devices, but it streamlines processes for compliance and efficiency, boosting the bottom line. It’s a win-win when you find the right talent. Typical Roles and Responsibilities in 𝗧𝗲𝗰𝗵𝗢𝗽𝘀 𝗤𝘂𝗮𝗹𝗶𝘁𝘆: · QA/QC Engineers · Quality Manager / Director / VP · Quality Analyst/Officer · Quality Compliance/Vendor/Supply Chain · GMP/GxP/GDP expert · Lean Expert · Process Excellence Expert · Downstream/Upstream · Project Manager · Manufacturing / Production Engineers Let's discuss our unique approach to #talentattraction, that we successfully deployed to niche industries. Book a call for further insights : shorturl.at/aeCRX #hiring #biopharma #careergrowth
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🌟 Key Skills for Excelling in Continuous Improvement in the Med Device Industry 🌟 Achieving excellence in the medical device industry requires a strong focus on continuous improvement. Here are the three essential skills professionals need: Regulatory Compliance Expertise 📜 Master the intricacies of ISO 13485 and FDA regulations. Staying compliant with these standards ensures product reliability and safety, minimizing risks and maintaining market approval. Data-Driven Analysis 📊 Develop proficiency in tools like Six Sigma and Lean methodologies. Using data to drive decisions helps identify areas for improvement, optimize processes, and enhance overall efficiency. Effective Communication and Feedback Integration 🧠🗣️ Hone your ability to communicate effectively and integrate customer feedback. This ensures that improvements align with market demands and enhances customer satisfaction and loyalty. At Grove Technical Resources, we connect top talent with leading companies in the medical device industry. Follow us for the latest insights and opportunities! #MedicalDevices #ContinuousImprovement #QualityManagement #RegulatoryCompliance #MedTech #StaffingSolutions #FollowUs #Hiring #QualityEngineer #manufacturingengineer
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