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Futran Solutions is seeking a qualified candidate in Marietta, Georgia, who possesses a Bachelor's degree in Engineering and 3+ years of experience in validation and manufacturing processes. The ideal candidate should have a strong understanding of IQ/OQ/PQ methodologies and medical device regulations such as FDA and ISO 13485.
The role requires familiarity with GMP, CAPA, and change control processes, along with excellent problem-solving and communication skills.
Bachelor’s degree in Engineering (Mechanical / Electrical / Biomedical / Manufacturing) or equivalent experience with 3+ years experience
Strong understanding of IQ/OQ/PQ methodologies and validation lifecycle
Knowledge of medical device regulations (FDA, ISO 13485)
Experience in manufacturing processes, equipment qualification, and process validation
Familiarity with GMP, CAPA, and change control processes
Ability to read and interpret engineering drawings, P&IDs, and technical specifications
Strong problem-solving and analytical skills
Excellent communication and documentation skills