Wimmer Solutions’ Post

Interviews can be daunting, especially in the highly regulated world of Medical Device manufacturing. Here are my top 5 tips for candidates stepping into Quality Assurance (QA) roles: 1. **Know the Regulations**: Familiarize yourself with the relevant regulations such as FDA's Quality System Regulation (QSR), ISO 13485, and EU MDR. Understand how they impact QA processes. This knowledge not only demonstrates your expertise but also shows your commitment to quality and compliance. 2. **Speak the Language of Quality**: Be prepared to discuss key quality concepts like CAPA (Corrective and Preventive Action), risk management, validation, and verification. Articulate how you've applied these in past roles or how you would in hypothetical scenarios. 3. **Detail-Oriented Examples**: Bring specific examples of how your attention to detail has made a difference in past projects. Whether it's catching a documentation error or improving a testing process, these stories will illustrate your value to the team. 4. **Continuous Improvement Mindset**: Show that you're not just about maintaining standards, but also about raising the bar. Discuss how you stay updated with industry trends and how you've contributed to continuous improvement initiatives in the past. 5. **Soft Skills Showcase**: QA roles involve cross-functional collaboration, so highlight your communication and teamwork skills. Discuss how you've worked with other departments to ensure quality and compliance. Remember, it's not just about technical know-how; it's about fitting into a culture that prioritizes patient safety through rigorous quality assurance. Good luck! #QualityAssurance #MedicalDevices #JobInterviewTips

🚨Sr. Associate - Quality for Computer Systems Validation🚨 I'm on the hunt for a QA Professional for Automation to join Lillys innovative team in #Limerick at their new Manufacturing Facility. #Lilly #Limerick is all about revolutionizing healthcare through next-gen #biopharmaceuticals. As a 𝗦𝗿. 𝗔𝘀𝘀𝗼𝗰𝗶𝗮𝘁𝗲 - 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗳𝗼𝗿 𝗖𝗼𝗺𝗽𝘂𝘁𝗲𝗿 𝗦𝘆𝘀𝘁𝗲𝗺𝘀 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻, you'll be diving headfirst into the exciting world of maintaining product quality and regulatory compliance specifically for Lillys computer systems. 𝗬𝗼𝘂𝗿 𝗿𝗼𝗹𝗲? To work hand-in-hand with Lillys amazing cross-functional team, implementing quality standards, supporting audits, and driving those all-important continuous improvement initiatives. If you think you've got what it takes, here's a sneak peek at what you'll be diving into: 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗔𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲 𝗢𝘃𝗲𝗿𝘀𝗶𝗴𝗵𝘁:  Developing and maintaining procedures, ensuring compliance, and making sure quality is at the heart of everything they do, especially when it comes to computer systems. 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲:  Keeping up to speed with industry regulations, assisting with inspections – you name it, you'll be on it, with a special focus on computer systems validation. 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗥𝗲𝗽𝗼𝗿𝘁𝗶𝗻𝗴:  Keeping those records shipshape and driving consistency across computer systems, ensuring they're fully validated and compliant. 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗜𝗺𝗽𝗿𝗼𝘃𝗲𝗺𝗲𝗻𝘁 𝗜𝗻𝗶𝘁𝗶𝗮𝘁𝗶𝘃𝗲𝘀: Optimizing Lillys systems validation processes. 𝗧𝗿𝗮𝗶𝗻𝗶𝗻𝗴 𝗮𝗻𝗱 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁:  Sharing your own expertise and staying on the cutting edge of quality assurance. 🎓 Bachelor's degree or higher in Science, Engineering, Quality, or a related field. 💼 3+ years of QA experience in biotech, pharma, or medical device manufacturing. 🧠 Strong knowledge of cGMP, FDA regulations, and quality risk management, with a focus on computer systems validation. 🤝 Excellent communication skills and a knack for teamwork. 🔍 Detail-oriented with a passion for maintaining top-notch quality, especially in computer systems validation. If you're ready to take the leap and join a team that's making a difference or you're just intrigued by the above, click the link to have a look at the full, detailed job description here 👉 https://e.lilly/3IFCN22 #BiotechInnovation #QualityAssuranceExpert #qualityassurancejobs #QualityAssurance #ComputerSystemsValidation #Limerick #LimerickJobs #PharmaIreland #WeAreLilly Jordyn Wintczak Ailís Dwyer Louise Quirke Richard O'Sullivan Kevin McCarthy (Talent Sourcing - US and Irish Market) Laura Heald Shane Lee Sean Heffernan Eoin O'Donovan Meggan Tully Stephanie Morrison Louise Quirke Katie O'Connor Conor Cronin Sharon Kennedy Ouda Rukundo Assoc. CIPD Richard Neylon Shauna O'Donovan Karen R. Juliette Lewis Aoife O Driscoll Catherine O'Sullivan

📣 medtech is on the radar this week ! 𝗛𝗲𝗿𝗲 𝗶𝘀 𝘁𝗵𝗲 𝘁𝗼𝗽 𝟱 𝗿𝗲𝗮𝘀𝗼𝗻𝘀 𝗮𝘀 𝘁𝗼 𝘄𝗵𝘆 𝘆𝗼𝘂 𝘀𝗵𝗼𝘂𝗹𝗱 𝗰𝗼𝗻𝘀𝗶𝗱𝗲𝗿 𝗮 𝗤𝗔/𝗥𝗲𝗴 𝗰𝗮𝗿𝗲𝗲𝗿: 𝟭. 𝗝𝗼𝗯 𝗦𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 Demand is currently outweighing supply within QA/RA functions. A real hype as the demands for quality & reg professional far outways the current supply, this is due to constant changes in regulations and standards making it more difficult to place a fully compliant medical device onto the market. So best time to get involved in this sector ! 𝟮. 𝗘𝗻𝘁𝗿𝘆 𝗹𝗲𝘃𝗲𝗹 '𝗼𝗽𝗲𝗻 𝗱𝗼𝗼𝗿' The combo of high market demands and talent shortage forces company to be more flexible when it comes to hire junior profiles. With the right set of standard knowledge, anyone with a heavy sense of details & market curiosity can jump into QA/RA career. 𝟯. 𝗔𝘂𝘁𝗼𝗻𝗼𝗺𝘆 Most of QA/RA roles are often project-based which means that you will be required to self manage your own workload to an extent. Working at your own pace and managing your workload results in a more satisfying career 𝟰. 𝗙𝘂𝗹𝗳𝗶𝗹𝗹𝗶𝗻𝗴 𝘄𝗼𝗿𝗸 Working in a health - science related segment or role is already an intrinsic motivation. QARA is all about safety and compliance hence seeing a medical device out on the market that you worked on changing lives provides a sense of satisfaction that other roles simply cannot offer. 𝟱. 𝗡𝗲𝘄 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 The constant updating of standards and regulations means you are always having to face new challenges, so if you seek a role that isn’t mundane then this is the right career path for you So Ready to start your career in #quality and #regulatory ! Book a call for further insights : shorturl.at/aeCRX #hiring #lifesciencejobs #medtech

📣 medtech is on the radar this week ! 𝗛𝗲𝗿𝗲 𝗶𝘀 𝘁𝗵𝗲 𝘁𝗼𝗽 𝟱 𝗿𝗲𝗮𝘀𝗼𝗻𝘀 𝗮𝘀 𝘁𝗼 𝘄𝗵𝘆 𝘆𝗼𝘂 𝘀𝗵𝗼𝘂𝗹𝗱 𝗰𝗼𝗻𝘀𝗶𝗱𝗲𝗿 𝗮 𝗤𝗔/𝗥𝗲𝗴 𝗰𝗮𝗿𝗲𝗲𝗿: 𝟭. 𝗝𝗼𝗯 𝗦𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 Demand is currently outweighing supply within QA/RA functions. A real hype as the demands for quality & reg professional far outways the current supply, this is due to constant changes in regulations and standards making it more difficult to place a fully compliant medical device onto the market. So best time to get involved in this sector ! 𝟮. 𝗘𝗻𝘁𝗿𝘆 𝗹𝗲𝘃𝗲𝗹 '𝗼𝗽𝗲𝗻 𝗱𝗼𝗼𝗿' The combo of high market demands and talent shortage forces company to be more flexible when it comes to hire junior profiles. With the right set of standard knowledge, anyone with a heavy sense of details & market curiosity can jump into QA/RA career. 𝟯. 𝗔𝘂𝘁𝗼𝗻𝗼𝗺𝘆 Most of QA/RA roles are often project-based which means that you will be required to self manage your own workload to an extent. Working at your own pace and managing your workload results in a more satisfying career 𝟰. 𝗙𝘂𝗹𝗳𝗶𝗹𝗹𝗶𝗻𝗴 𝘄𝗼𝗿𝗸 Working in a health - science related segment or role is already an intrinsic motivation. QARA is all about safety and compliance hence seeing a medical device out on the market that you worked on changing lives provides a sense of satisfaction that other roles simply cannot offer. 𝟱. 𝗡𝗲𝘄 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 The constant updating of standards and regulations means you are always having to face new challenges, so if you seek a role that isn’t mundane then this is the right career path for you So Ready to start your career in #quality and #regulatory ! Book a call for further insights : shorturl.at/aeCRX #hiring #lifesciencejobs #medtech

🔍 Top Tips for QA Interviews in Medical Device Manufacturing 🔍 Interviewing for a Quality Assurance (QA) position in the Medical Device sector can be challenging, but with the right preparation, you can stand out. Here are my top 5 tips to help you succeed: 1. **Know the Regulations** ✅ Medical Device manufacturing is heavily regulated. Familiarise yourself with ISO 13485, FDA regulations, and any other relevant standards. Demonstrating your knowledge of these can show your commitment to maintaining high-quality standards. 2. **Highlight Your Attention to Detail** ✅ QA roles require meticulous attention to detail. Share specific examples from your past experiences where your keen eye caught potential issues before they became problems. This can illustrate your proactive approach and reliability. 3. **Understand the Product Lifecycle** ✅ Be prepared to discuss how QA fits into the entire product lifecycle, from design to post-market surveillance. Showing that you understand the big picture can set you apart from other candidates. 4. **Showcase Problem-Solving Skills** ✅ QA professionals often need to troubleshoot and resolve issues quickly. Highlight instances where you've successfully identified and addressed quality issues, explaining your thought process and the outcomes. 5. **Stay Updated with Industry Trends** ✅ The Medical Device industry is always evolving. Stay informed about the latest trends, technologies, and best practices. Mentioning recent advancements during your interview can demonstrate your enthusiasm and dedication to continuous learning. Remember, preparation is key. Good luck with your interview! If you have any questions or need further advice, feel free to reach out. #QualityAssurance #MedicalDevices #JobTips For more insights, visit hero.ie.

📣 medtech is on the radar this week ! 𝗛𝗲𝗿𝗲 𝗶𝘀 𝘁𝗵𝗲 𝘁𝗼𝗽 𝟱 𝗿𝗲𝗮𝘀𝗼𝗻𝘀 𝗮𝘀 𝘁𝗼 𝘄𝗵𝘆 𝘆𝗼𝘂 𝘀𝗵𝗼𝘂𝗹𝗱 𝗰𝗼𝗻𝘀𝗶𝗱𝗲𝗿 𝗮 𝗤𝗔/𝗥𝗲𝗴 𝗰𝗮𝗿𝗲𝗲𝗿: 𝟭. 𝗝𝗼𝗯 𝗦𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 Demand is currently outweighing supply within QA/RA functions. A real hype as the demands for quality & reg professional far outways the current supply, this is due to constant changes in regulations and standards making it more difficult to place a fully compliant medical device onto the market. So best time to get involved in this sector ! 𝟮. 𝗘𝗻𝘁𝗿𝘆 𝗹𝗲𝘃𝗲𝗹 '𝗼𝗽𝗲𝗻 𝗱𝗼𝗼𝗿' The combo of high market demands and talent shortage forces company to be more flexible when it comes to hire junior profiles. With the right set of standard knowledge, anyone with a heavy sense of details & market curiosity can jump into QA/RA career. 𝟯. 𝗔𝘂𝘁𝗼𝗻𝗼𝗺𝘆 Most of QA/RA roles are often project-based which means that you will be required to self manage your own workload to an extent. Working at your own pace and managing your workload results in a more satisfying career 𝟰. 𝗙𝘂𝗹𝗳𝗶𝗹𝗹𝗶𝗻𝗴 𝘄𝗼𝗿𝗸 Working in a health - science related segment or role is already an intrinsic motivation. QARA is all about safety and compliance hence seeing a medical device out on the market that you worked on changing lives provides a sense of satisfaction that other roles simply cannot offer. 𝟱. 𝗡𝗲𝘄 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 The constant updating of standards and regulations means you are always having to face new challenges, so if you seek a role that isn’t mundane then this is the right career path for you So Ready to start your career in #quality and #regulatory ! Book a call for further insights : shorturl.at/aeCRX #hiring #lifesciencejobs #medtech

Good opportunities

Opportunity

📣 medtech is on the radar this week ! 𝗛𝗲𝗿𝗲 𝗶𝘀 𝘁𝗵𝗲 𝘁𝗼𝗽 𝟱 𝗿𝗲𝗮𝘀𝗼𝗻𝘀 𝗮𝘀 𝘁𝗼 𝘄𝗵𝘆 𝘆𝗼𝘂 𝘀𝗵𝗼𝘂𝗹𝗱 𝗰𝗼𝗻𝘀𝗶𝗱𝗲𝗿 𝗮 𝗤𝗔/𝗥𝗲𝗴 𝗰𝗮𝗿𝗲𝗲𝗿: 𝟭. 𝗝𝗼𝗯 𝗦𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 Demand is currently outweighing supply within QA/RA functions. A real hype as the demands for quality & reg professional far outways the current supply, this is due to constant changes in regulations and standards making it more difficult to place a fully compliant medical device onto the market. So best time to get involved in this sector ! 𝟮. 𝗘𝗻𝘁𝗿𝘆 𝗹𝗲𝘃𝗲𝗹 '𝗼𝗽𝗲𝗻 𝗱𝗼𝗼𝗿' The combo of high market demands and talent shortage forces company to be more flexible when it comes to hire junior profiles. With the right set of standard knowledge, anyone with a heavy sense of details & market curiosity can jump into QA/RA career. 𝟯. 𝗔𝘂𝘁𝗼𝗻𝗼𝗺𝘆 Most of QA/RA roles are often project-based which means that you will be required to self manage your own workload to an extent. Working at your own pace and managing your workload results in a more satisfying career 𝟰. 𝗙𝘂𝗹𝗳𝗶𝗹𝗹𝗶𝗻𝗴 𝘄𝗼𝗿𝗸 Working in a health - science related segment or role is already an intrinsic motivation. QARA is all about safety and compliance hence seeing a medical device out on the market that you worked on changing lives provides a sense of satisfaction that other roles simply cannot offer. 𝟱. 𝗡𝗲𝘄 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 The constant updating of standards and regulations means you are always having to face new challenges, so if you seek a role that isn’t mundane then this is the right career path for you So Ready to start your career in #quality and #regulatory ! Book a call for further insights : shorturl.at/aeCRX #hiring #lifesciencejobs #medtech

🔮Let us fast forward to 2035. =>=>=>=>=>=>=>=>=>=>=>=>=>=>=>=>=> ❓ In about 10 years from now, what would a QA/RA professional look like in the medical device industry? ✅List the top 3 "must have" skills you believe QA/RA professionals would need to have in the not-so-distant future?