Need Mechanical Engineer – Process Validation in - Must be from Medical Device - Domain BR# 131120BR SR# ERS-/ERS-/2014/375600 Role: Mechanical Engineer – Process Validation Duration: 6-12 Months Work location: Irwindale, CA 91706 Hiring Mode (TP /FTE): TP Only Mandatory Domain: Mechanical Engineering & Medical Devices industry Experience Level: 5-10 years Educational qualification (if must): BS/MS Degree in Mechanical Engineering OR Equivalent degree How many level of internal interview (TP1/TP2/Both): 2 rounds (one telephonic, one F2F/Skype) Mandatory Skills: Need to have Strong Process validation experience in medical devices industry. Strong medical devices industry experience. Need to have Mechanical engineering background. Required skills: 3+ years of medical device process development experience in production environment. Degree in Mechanical Engineering - B.E / B.Tech / B.S / M.E / M.Tech / M.S Knowledge of medical device design controls. Performs and directs process validations, IQ, OQ, PQ, TMVs as required. Oversees the validation program: schedules, files, and records. Administers validation training for the facility Demonstrated knowledge of risk management techniques. Interfaces with Quality and Manufacturing Engineers to review processes, determine validation requirements, and coordinate the validation. Demonstrated knowledge of CAPA process and root cause investigation. Coordinates and performs testing relating to the validation. Familiar with working within formal design control processes, writing test protocols and reports. Works with suppliers, management, Engineers, and Manufacturing Associates in the resolution of quality problems associated with the validation program. Performs internal and external audits associated with validation activities. Utilizes advanced statistical tools to determine sampling plans and to analyze data associated with validation activities. Oversees and directs the activities of the Validation Engineers / Technicians Proven record of interpersonal skills to handle client, Result oriented and self-driven.
Posted on: Mon, 03 Nov 2014 20:24:00 +0000
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