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Check out JobsAI Senior Quality Engineer - Medical Device Quality Systems
Company Name
Pfizer
Job Overview
Responsible for Kalamazoo site Quality Systems for Medical Device/Combination Products. Supports the creation, development and monitoring of Quality and Regulatory Compliance strategies. Ensures inspection readiness and compliance with regulations. Integral to continual improvement, supports quality systems improvement efforts, and ensures timely escalation of issues.
Requirements
- Requires a bachelor's degree with 2+ years of experience or an equivalent combination of education/experience.
- Must have knowledge of FDA Quality System Regulations and ISO 13485:2016.
- Experience in Medical Device or Combination Products Quality.
- Understanding of Quality Management Systems in a GMP environment.