Orthopedic devices researcher with 3-year experience in an industrial research/service organization. Experienced in the product realization process, FDA 510(k) clearance, quality system and pilot production in the Biomaterial Production GMP. Strong analytical, logical thinking and detail-oriented.
Specialties:
鈥SO 13485, 10993, 14971
鈥uality System Development
鈥esearch/pilot Plant Management
鈥isk management, control and analysis
鈥egotiation with regulators
鈥inimally invasive surgical procedures
鈥mplantable devices
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