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Quality

World Quality Day! Being a Quality Pro in Medical Devices and Pharma: Like Being the “Fixer” in an Action Movie

World Quality Day! Being a Quality Pro in Medical Devices and Pharma: Like Being the “Fixer” in an Action Movie

Ever thought about who keeps the heroes (and sometimes villains) in check in your favorite action movies? That’s right—the fixer, the problem-solver, the behind-the-scenes mastermind helping to ensure everything goes according to plan. In the world of medical devices and pharmaceuticals, quality professionals are like the “fixers”. They’re the unsung heroes who make sure every product is safe, effective, and reliable. Here’s how being a quality pro is like being the ultimate behind-the-scenes operator in a high-stakes blockbuster!

1. *Mission Impossible*: Navigating Complex Regulations

Think of quality professionals as Ethan Hunt from *Mission: Impossible*, navigating an endless maze of regulations, from the FDA’s 21CFR 211 to ISO 13485 for medical devices. Imagine if Hunt had to memorize every detail of the mission, assess all risks, and then execute flawlessly—because if he didn’t, it would be game over for the product, the patients, and sometimes even the company.

Being a quality pro means taking on a similar mission. The stakes are high, and the regulations are always evolving. Whether it’s a new rule from the FDA or an update to the EU Medical Device Regulation (MDR), there’s always a new “mission” to tackle. It’s a job where failing to meet requirements isn’t an option—just like Hunt, quality pros are always thinking, “Your mission, should you choose to accept it…”

2. *Doctor Strange*: Mastering the Multiverse of Compliance

Imagine juggling multiple realities—each with its own rules, risks, and considerations. It’s a lot like Doctor Strange manipulating time and space in Marvel’s *Doctor Strange*. In the quality universe, professionals have to think about everything from product design to manufacturing processes and post-market surveillance. Each phase has its own set of rules and missing a single one can throw the whole process out of alignment.

For a quality pro, every day is a balancing act. They predict potential risks, create processes to minimize risks, and make sure teams are on board. This requires an almost supernatural level of focus and flexibility, much like Strange bending reality to solve a problem. One moment they’re in meetings with engineers, the next they’re working with regulatory affairs, bending and weaving between departments to keep the product journey smooth.

3. *Sherlock Holmes*: The Ultimate Problem Solver

Have you ever seen Sherlock Holmes in action, uncovering details no one else would notice? Quality professionals embody this same detective mindset, particularly during CAPAs (Corrective and Preventive Actions) and investigations. When something goes wrong—like a deviation in a manufacturing process or an adverse event reported with a device—the quality pro puts on their metaphorical deerstalker hat and starts investigating.

They dive deep into root causes, analyze data, interview team members, and review processes to find the solution. A quality professional’s favorite tool might as well be a magnifying glass! They don’t just stop at solving the issue; they make sure it doesn’t happen again. Like Sherlock, they uncover the “why” and “how” to ensure the product (and the company) is protected from future risks.

4. *James Bond*: Staying Cool Under Pressure

Let’s not forget that being a quality professional means handling a lot of pressure. Think James Bond, calmly sipping his martini while defusing a bomb—quality pros need that same unshakeable cool when things go wrong. If a batch is found to have a defect, or if a new regulation suddenly impacts a product line, the entire team looks to the quality department for solutions.

Whether it’s responding to audits or handling inspections, quality is always ready. They need to keep calm, understand the issue, and work with cross-functional teams to fix it fast. They know how to keep everyone focused and moving forward. Bond may have Q and M backing him up, but a quality pro has the entire organization counting on them.

5. *Tony Stark*: Innovating to Stay Ahead

Quality professionals aren’t just there to follow rules; they’re also trailblazers who find innovative solutions to complex problems. In the world of *Iron Man*, Tony Stark is constantly tweaking, improving, and re-engineering. Similarly, quality pros work with engineering and R&D to develop products that not only meet but exceed regulatory requirements.

They’re the ones who push for improvements in design, manufacturing processes, and safety testing, all while ensuring compliance. Just like Stark builds suits that protect him, quality professionals work to build safer, more reliable medical devices and drugs that protect patients. There’s no such thing as “good enough” in quality—just like Tony Stark, they’re always thinking, “How can we make this better?”

So Why Do It?

Being a quality professional is a tough job with endless puzzles, high stakes, and a lot of responsibility. But here’s the thing: it’s also one of the most rewarding roles out there. Quality pros know that every risk they mitigate, every defect they catch, and every process they improve could mean a safer experience for someone, somewhere. In this blockbuster, there’s no red carpet or instant fame, but there’s immense satisfaction. And in the end, knowing you’re the hero behind the scenes? That’s worth every challenge.

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Jackie Torfin - CEO and Principal Advisor for QLeaR Advisors

About Jackie Torfin

Jackie has over 30 years experience and deep expertise in quality, regulatory, pre-clinical and clinical compliance. She has served in Senior Global roles for companies including Beckman Coulter, NAMSA, CIMA Labs, PDL BioPharma, Arizant/3M, and Heraeus.

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