Quality & Regulatory Leader - NPD
- Gurgaon, India
About Stryker Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
- Partner with R&D at the same eye level: Should have engineering and product development experience so that he can work hand in hand with R&D.
- Product focused: Should be able to balance design controls in accordance with product risk and compliance and regulatory requirements.
- Inspires others: Relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride.
- Delivers results: A driven player/coach who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks.
Responsibilities and duties
- Own the quality management system : develop new systems and procedures for NPD group.
- Prepare a project specific quality strategy based on product risk and compliance requirements
- Influence across departments (i.e. Sourcing, Quality, Regulatory) to support supplier quality strategy and make sound decisions on supplier strategy and site direction.
- Responsible for operations support, supplier development, incoming efficiencies, and regulatory compliance.
- Support products development and customer experience including issue investigation, corrective action, preventive action and risk management.
• Manage supplier quality processes and resolution of supplier issues
- Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met.
What You need
- Bachelor's in a science, engineering or related field.
- Minimum of 12 years relevant quality experience in GMP manufacturing environment in Medical Device, Pharma, Automotive, Consumer Durable or Aerospace industry Supervisory experience preferred.
- Rich experience in product development , specifically system architect or developer of mechatronic devices
- Thorough knowledge of current regulations, pertinent regulatory guidance and industry trends.
- Establish / own quality management systems is essential.
- Must have experience in using PFMEA's, Control Plans, & Process Flows.
Know someone at Stryker? Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.
Back to top