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Quality Engineer III/ Consumer Affairs Specialist III


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Job Title:Quality Engineer III/ Consumer Affairs Specialist III
Job ID :15902
Location:Carlsbad CA 92008
Duration:7 Months

Job Description
Determines reportability (MDR/MDV) of complaints to FDA and other international regulatory agencies.
Evaluates incoming requests from the FDA and European Competent Authorities.
Reviews and interprets risk management documentation as appropriate.
Reviews and interprets trends associated with complaint events.
Reviews complaint records and identify appropriate internal department(s) to obtain relevant information and coordinate efforts to compile relevant data.
Provides technical expertise and ensures response questions are answered completely and in compliance with all government agency regulations.
Responds to and tracks requests for additional information from government agencies.
Ensures record documentation is maintained in a constant state of audit readiness per internal policies.
Manages and organizes workflow to accommodate strict deadlines.
Communicates with internal and external customers and vendors at various levels.
Negotiates with others to reach understanding or agreement.
Works independently under limited supervision.
Participates in team decision making and displays team problem solving/communication skills.

Required Education:
Registered Respiratory Therapist.

Required Years Of Experience:
7+ years in complaint handling experience and specifically in MDR and MDV reporting.

Additional Competency and Experience:
Knowledge of FDA, MEDDEV, Canadian Regulations.
Experience with medical device complaint handling and quality assurance.
Knowledge of medical device use, preferably ventilators.
Working knowledge of medical devices, their development and quality control.
Knowledge of quality control concepts.
Self-starter with proven ability to successfully work with minimal supervision.
Ability to write business and technical documents with minimal supervision.
Strong analytical skills including trend and statistical analysis.
Demonstrated leadership skills and ability to influence others

Contact Person: Manju

If you are interested in this job then you can reach me at 2015249600 X 7944

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