Vrushank Shah
- Role
- Senior Manager Quality Systems at BD
- Location
- Palatine, IL, US
- LinkedIn followers
- 500 followers
About Vrushank Shah
15 years of experience in cGMP and FDA-regulated medical and pharmaceutical…
Experience
Senior Manager Quality Systems
Sep 2023 — Present
Lead and manage a team of quality personnel to develop and implement effective QMS that comply with medical device standards and regulations.(e.g. FDA, ISO)- Identify process inefficiencies and implement continuous improvements to enhance the effectiveness and efficiency of quality systems and processes.(e.g. six sigma/lean projects)- Establish and track quality metrics, generate reports, and provide insights to drive data-driven decision-making and continuous improvement efforts.(e.g. management review, KDGs)- Lead preparations for external audits and host auditors in the front room.(e.g. BSI, FDA, MDSAP)- Collaborate effectively with cross-functional teams (e.g. RA, R&D, operations and others)
Skills
- Pharmaceutical Industry
- Pharmacueticals
- Sop
- Microsoft Office
- Continuous Improvement
- Product Complaints
- Lean Six Sigma
- Lean Manufacturing
- Medical Devices
- Quality Operations
- Microsoft Excel
- Fda
- Validation
- Quality Auditing
- Research
- Chemistry
- Corrective and Preventive Action (Capa)
- Gmp
- Customer Service
- Quality Assurance
- Capa
- Public Speaking
- Leadership
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