Chris S.
Versatile Quality Assurance Expert | Visionary to Optimize and Deliver | Global Regulatory Affairs | Drive for Efficiency | Change Leader
- Role
- Head of Plant Quality at Intuitive
- Location
- Charlottesville, VA, US
- LinkedIn followers
- 500 followers
About Chris S.
With over two decades of unwavering commitment to the medical device industry, I bring a wealth of experience as a seasoned quality assurance professional to the forefront. Throughout my career, I have consistently demonstrated a proven ability to lead global teams, establish effective quality management systems, and drive initiatives aimed at enhancing processes. What sets me apart is my innate talent for dissecting complex situations and catalyzing improvements, extending seamlessly beyond Quality Assurance to collaborative efforts with departments such as Operations, Regulatory Affairs, and Supply Chain.My leadership journey has taken me to diverse jurisdictions within the US and EU, where I\'ve successfully overseen Quality Assurance teams ranging from 80 to 650 associates. Each unique facility presented its own set of distinctive challenges and opportunities, all met with unwavering dedication to achieving success.In addition to my core responsibilities, I have consistently embraced opportunities to take on additional projects and challenges. Whether assuming roles beyond my core expertise or tackling large-scale initiatives like the SAP S4 HANA re-implementation, I thrive on pushing boundaries and driving meaningful change.As you may notice in my profile background, there\'s a picture of my older vehicle on a racing track. This amateur \"hobby\" not only represents a personal passion but also mirrors my dedicated professional mindset. Racing on the track is inherently filled with risk, and it\'s all about finding that delicate balance between risk and reward in every single turn and braking zone. Going into a corner too aggressively can lead to disaster, but the goal is to maintain maximum speed throughout the entire track without any incidents.This analogy reflects how I approach my role as a leader and process improvement. I\'m driven to push the limits as hard as I can, akin to accelerating on the racetrack. However, I\'m always mindful not to push things to the point of breaking. Instead, I aim to maintain a delicate balance, pushing boundaries while ensuring that the system remains intact and resilient. The ultimate objective is to keep the momentum going and reap the benefits of those calculated risks, just as in racing, where the goal is to maintain speed and achieve peak performance without setbacks.
Experience
Head of Plant Quality
Apr 2024 — Present · Blacksburg, VA, US
Leading the plant quality function for the Blacksburg facility.
Education
Virginia Tech
BS, Industrial & Systems Engineering
Virginia Tech - Pamplin College of Business
MBA
Skills
- Medical Device Registration
- Quality System
- Quality Systems
- Patents
- Process Improvement
- Cross-Functional Team Leadership
- Iso 14971
- Six Sigma
- Quality Auditing
- Sunshine Act
- Quality Assurance
- Validation
- Iso
- Fda
- Design Control
- Medical Devices
- Capa
- Continuous Improvement
- Compliance
- Aggregate Spend Compliance
- Management
- Ce Marking
- Quality Management
- Lean Manufacturing
- Iso 13485
- Fda Gmp
- Regulatory Affairs
- U.s. Food and Drug Administration (Fda)
- Manufacturing
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