Eliezer De Jesus

I just watched the third episode of The Futurist from Medtronic. This episode focuses on brain computer interfaces and features three experts in their respective fields discussing #BCI. #MedtronicEmployee

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The foundation for the Leadership Think Tank (LTT) is one click away. Nothing to lose and so much to gain. https://lnkd.in/gCqMy5T7 #goodread #achievingabreakthroughtransformation #LTT

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Thermo Fisher Scientific released its 2023 Corporate Social Responsibility (CSR) report, containing 88 pages filled with information and data on how we are fulfilling our Mission to enable our customers to make the world healthier, cleaner and safer. The report tells the larger Thermo Fisher story, including how we put quality at the center of everything we do, and is the responsibility of every colleague. The report provides a closer look at different parts of our operations, including the important work done by the Quality & Regulatory Affairs (Q&RA) team such as our Quality Policy, Corrective and Preventive Actions (CAPA) and our innovative Making Quality Personal experience, which is transforming how we approach our jobs. These and many other measures are helping ensure that Thermo Fisher operates with integrity and transparency, meeting the highest quality and ethical standards while strictly adhering to global regulatory compliance. Our CSR report fills me with pride in all our people and the Q&RA team. The report’s pages are filled with the dedication and ingenuity of more than 120,000 colleagues worldwide working in thousands of ways to turn our Mission into positive results. #QualityProfessionals #QualityAssurance #RegulatoryAffairs #QARA #Regulatory #Quality #innovation #sustainability #CSR #CorporateSocialResponsiblity #givingback #socialimpact

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One of the major challenges of any kind of quality or process improvement effort is deciding where to draw the organizational boundaries around your initiative. There seems to be an inverse relationship between "how much of the apple you try to bite off at once" and "successfully taking a bite without breaking a tooth." It's easier to pull something off just within a single team or department, but far less impactful. On the other hand, enterprise-wide change can have a huge impact but is far more complicated to pull off. For a fantastic and entertaining example of this, take an hour and listen to this podcast episode from #ThisAmericanLife: Episode #561 - NUMMI (2015) "A car plant in Fremont California that might have saved the U.S. car industry. In 1984, General Motors and Toyota opened NUMMI as a joint venture. Toyota showed GM the secrets of its production system: How it made cars of much higher quality and much lower cost than GM achieved. Frank Langfitt explains why GM didn't learn the lessons—until it was too late."

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Navigating Modern Quality Challenges with Ancient Wisdom: A Call for Critical Thinking In the lastest edition of Quality Progress Magazine, the article written by Brain Motter titled "History Lessons" discusses how incidents at notable companies like Ford Motor Co. and Philips Respironics underscore a broader industry trend that could signal trouble ahead for manufacturing as well as service industries. Despite their maturity and expertise, these companies faced significant setbacks due to quality issues—Ford with its multiple vehicle recalls and Philips with its CPAP machine hazards. This predicament invites a crucial question: How can organizations preempt such crises in the future? The answer might just lie in the educational approaches of the past. The Socratic method, renowned for fostering critical thinking through rigorous questioning, could be pivotal in equipping today's workforce. This method builds the necessary skills to not only anticipate, but address emerging challenges. Here are five key elements of the Socratic method that can enhance quality management: 1️⃣ Asking open-ended questions rather than stating opinions. 2️⃣ Probing gently for inconsistencies in reasoning. 3️⃣ Identifying underlying principles that drive decisions. 4️⃣ Using concrete examples to clarify points. 5️⃣ Avoiding claims of expertise to foster a culture of continuous learning and questioning. By encouraging more questions than answers, this approach promotes continuous inquiry along with deeper analysis, essential for navigating complex quality issues. Furthermore, incorporating empirical methods into training programs, as advocated by ancient Greek philosophers, could enhance decision-making skills. Reading along with application with the works of these thinkers can provide valuable insights that are surprisingly relevant to modern-day challenges. For instance, reintroducing basic geometry/metrics through Euclid's principles could strengthen problem-solving abilities, particularly in manufacturing contexts where precision is paramount. Seeing these problems arise from these two large companies gives rise to consider pivoting towards more rigorous, thoughtful approaches to quality management. Embracing the principles of the Socratic method, in addition to empirical learning will not only address immediate quality issues but also foster a culture of proactive problem-solving and continuous improvement. Let's not wait for the next crisis to rethink our strategies. The history of philosophy and science offers timeless lessons that can help steer our future toward greater reliability and innovation in manufacturing. #QualityManagement #CriticalThinking #EmpiricalApproach #ContinuousImprovement

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The word #resilience has been presenting itself often the last couple months. I've never noticed a specific word being used so often in so many settings by so many different people. From a business leader during a presentation, to 1:1 meetings, and then I saw this graphic today. Every day we are faced with challenges and things not turning out as we expected. We may be disappointed, frustrated, overwhelmed and that's ok. It is how we channel that energy to move forward in a positive way that enables growth. Doing hard things requires resilience, but hopefully leads to fulfillment. Edit: I realized the source of this image was not apparent so I traced it back to this article by Natalie Frank on how to build resilience. https://lnkd.in/eXc4tuui

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Embracing Servant Leadership In today's fast-paced industry, the importance of Servant Leadership cannot be overstated. As we navigate and support our strategic goals, the role of a Servant Leader emerges as a critical element in achieving success. Servant Leadership is not about individual accolades or recognition. It's about fostering a culture where the success of the team takes precedence over personal achievements. The focus shifts from the self to the collective, prioritizing the growth, well-being, and development of team members. The catch-22 here is that while aspiring leaders often strive for personal success, the true impact of leadership comes from enabling others to succeed. It’s a paradox where stepping back from the spotlight often results in the most profound and lasting influence. For those new to Servant Leadership, the journey begins with active listening and genuine empathy. Understanding your team’s needs and challenges is the foundation. Investing in their growth, fostering a sense of community, sharing power, and leading by example are crucial steps in this process. In a landscape where personal career growth often leads individuals to become solitary contributors, Servant Leadership offers a refreshing alternative. It reminds us that true success in a company isn't solely built on personal skills and education, but on the ability to uplift and empower others. By adopting Servant Leadership, we create an environment where collaboration flourishes, innovation is encouraged, and morale is boosted. When leaders prioritize the needs of their team, the entire organization benefits from increased loyalty, enhanced performance, and a stronger, more cohesive culture. The true measure of a Servant Leader's success is not in the recognition they receive, but in the achievements and growth of those they lead. By celebrating the accomplishments of the team, Servant Leaders find fulfillment in the collective triumphs of their organization. Embrace Servant Leadership not as a means to an end, but as a transformative approach that drives organizations to new heights, creating a more supportive and innovative workplace and making lasting, meaningful impacts on those you lead.

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The FDA has published its final guidance on #remanufacturing, #repairing, and #servicing of #MedicalDevices. The #FDA issued this guidance "[b]ecause of the apparent confusion between servicing and remanufacturing" that exists within the industry. I have spent a lot of time working with #device companies on this topic and almost every time I audit a #QualitySystem, I discuss this topic. With #SaMD companies, there is always a debate as to whether it is even possible to service #software. I can think of VERY FEW situations that meet the definition of "servicing" for #MedicalDeviceSoftware. The guidance makes clear that "servicing" is distinctly different in the context of software as compared to a physical #MedicalDevice. Unfortunately, the FDA did not shed much light on this distinction. The few examples that the Agency provided and the limited discussion of the application of these terms in the software context is a missed opportunity to help the #DigitalHealth industry meet its #compliance obligations. I'm disappointed and hope the Agency will update this guidance or issue a new guidance specific to software (with discussions around cybersecurity and AI-enabled devices, among others) sometime soon. Reach out to us at Brooke & Associates if you'd like to make sense of this guidance and how it applies to you! #QMS #ISO13485 #QualityManagementSystems #QualityControl #QualityAssurance #RegulatoryAffairs #RAQA #QARA #AI #AIaMD #DHCoE

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Last month, I visited the global headquarters of UL Solutions (Underwriters Laboratories) in Northbrook, Illinois, home to one of our trusted, product certification partners. Many of our businesses rely on UL Solutions to certify products, as do more than 60% of Fortune Global 500 companies in more than 100 countries, and more than 21,000 organizations in nearly every industry. The UL mark appears on billions of products.   In addition to meeting the team and some expert UL Solutions engineers, I toured some of their laboratories, including UL Solutions’ state-of-the-art electromagnetic (EMC) and electric vehicle (EV) testing facility and facilities used to conduct fire testing of large-scale materials, fire suppression and fire detection. As representatives of companies dedicated to product quality, safety and compliance, we discussed our shared commitment to continuing our traditions of excellence and leadership in those areas, especially as the expectations and requirements of customers, regulators and other stakeholders evolve and grow. Committed UL Solutions’ compliance and safety professionals working in a network of extensively equipped laboratories around the world are an integral part of our ability to meet our commitments to customers.    Thermo Fisher Scientific Quality & Regulatory Affairs (Q&RA) operates a multi-step process, including the thorough scrutiny of internal and external experts, to ensure the quality, safety and compliance of our many products. #QualityProfessionals #QualityAssurance #RegulatoryAffairs #QARA #Regulatory #Quality #MedicalDevices #PatientSafety #RegulatoryComp #QualityControl #productcertification #RegulatoryCompliance #ulsolutions #medicaldevicesafety #medicaldevicetesting

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My team will find this hilarious coming from me as I’m the worst at this, but as we are coming into the vacation season it’s good for all of us to challenge ourselves and each other not just during the vacation season but daily. It’s easy to get caught up in the hustle and bustle of work and forget to prioritize our own well-being. However, taking time for yourself is crucial for maintaining a healthy work-life balance. Whether it's spending time with loved ones, engaging in a hobby, or simply relaxing, down time and self-care are essential for recharging and avoiding burnout. Remember to make time for yourself and prioritize your mental and physical health. #bvi #selfcare #wellness #worklifebalance #fieldservice #medicaldevices

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🙏🏻 Humbled to have my recent post (https://lnkd.in/ebpTswgr) turned into a blog by Vrushali Negandhi and Eminence Group Ventures FZCO - A Eminence Group Company - great additional insights! ~~~ If you found this interesting or helpful, consider Reposting 🔄; follow me Vincent F. Cafiso and click the 🔔 so you don't miss future content.

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Some great insight regarding downsizing and restructuring and how it is usually myopic and reactive in nature. Biggest takeaway is that most managers/execs don't understand the longer term negative impact of not retaining talent and only thinking about the immediate expendature savings aspect.

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If you want a high-performing team, you need to be a high-performing leader. 🌟 Inspiring your employees to reach new heights requires strategic delegation, constructive feedback, a heavy dose of emotional intelligence, and accountability. How are you leading by example in your organization? #HighPerformingTeams #PerformanceManagement #LeadershipStrategy

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Great Reads on - Managing a Team - There are so many great books on leadership.  Here are few that are particularly useful for leading a team of people that report to you: 1) Creating Magic - Lee Cockerell: https://a.co/d/hWo6NVx 2) The Ideal Team Player - Patrick Lencioni: https://a.co/d/1MP4UZG 3) First, Break All The Rules - Marcus Buckingham: https://a.co/d/5aVTGCk Share your favorites in the comments!

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Goal setting isn't just about aiming high—it's about creating a roadmap to success that's clear, actionable, and inspiring. For me, as someone deeply involved in the medical device manufacturing field, goal setting is a strategic process. It starts with a clear vision of where we want to go, whether it's improving product quality, enhancing customer satisfaction, or innovating new designs. Breaking down these goals into smaller, achievable steps keeps us motivated and on track. It's about celebrating each milestone, knowing that each step forward brings us closer to our ultimate objectives. Flexibility is key, especially in our fast-paced industry. Adapting goals as circumstances change ensures we remain agile and responsive to market demands and technological advancements. Let's set our sights high and achieve greatness together in the Medical Instruments field! #Goalsetting #Growingheights #Goals #Reachingheights

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📣I am excited to share that I will be speaking at this upcoming Webinar hosted by Quality Digest and sponsored by ComplianceQuest. 🔖Title: Navigating Leadership: Fostering Continuous Improvement and Total Quality Management to Drive Organizational Excellence 📅 Date: Tuesday, June 25, 2024 🕚 Time: 11:00 AM-12:00 PM PST 📍Location: Zoom 💲Price: Free! Why you should join: ✅ Join us for a transformative webinar, where we will explore embracing Continuous Improvement and Total Quality Management to drive Organizational Excellence. Learn key strategies to elevate engagement, foster growth, and ignite innovation within your teams. 👇Registration information below 🔄If you found this post interesting, consider liking, reposting or sharing with your network!

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Personal Habits vs. Universal Habits Have you ever stopped to consider how much of your personal habits are being overshadowed by universal habits imposed by daily routines and societal expectations? Often, the demands of everyday life consume so much of our time and energy that we unintentionally neglect the personal habits that bring us joy and fulfillment. These personal habits, whether it's exercising, reading, spending time with family, or engaging in hobbies, are crucial for our mental and emotional well-being. While universal habits are designed to help us navigate daily responsibilities and commitments, they can sometimes create a monotonous cycle that leaves little room for personal growth and happiness. It's essential to be aware of this dynamic and consciously make time for the habits that matter most to you. Remember, you are not just fulfilling roles and responsibilities; you are a unique individual with passions and interests that deserve attention. Balancing these universal habits with personal habits is key to maintaining a fulfilling life. Don't let routine demands overshadow the activities that move your heart and mind. Make a commitment to conserve and prioritize your personal habits, especially the ones that remind you of who you are and why you are special. Embrace the balance and ensure that your life is as enriching personally as it is in your daily roles.

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This is such a true statement. If you expect those under you to perform in a way similar to you then you need to be a visible leader and live up to those expectations. If you behave in a way that is contrary to your expectations, they will never take you seriously and you will have a hard time influencing them at all.

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