Principal Eng, Quality Assurance
vantive
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Experience: 8+ Years
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Bengaluru
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Posted 4 days ago
Job Description
- Demonstrated compliance knowledge in the areas of medical device and drug product development, change control, NCR CAPA, and risk management.
- Strong verbal and written communication skills
- Strong interpersonal/communication/influencing/negotiation skills required.
- Demonstrated leadership, teaming, and communication skills accomplishing success with large teams.
- Device regulation (design control) experience required
- Knowledge of FDA (21 CFR Part 210, 211, 820, 803, 806), ISO 13485, ISO 14971, IEC 60601, and standards for medical devices and therapeutics.
- Strong analytical and problems solving skills utilizing DMAIC tools, Six Sigma Engineering, ASQ or other certifications desirable.
- Proficient with Minitab or any equivalent statistical tool is required.
- Proficient in product and process change controls and risk management
- Apply DMAIC and statistical techniques to address issues and investigations
- Demonstrates ability to work independently