Job Description

The RA Engineer I will be responsible for performing product surveillance activities for all medical devices and is responsible for assisting in the investigation of complaints and reportable events. Interfaces with OEMs and local departments to promote quality improvements to both products and quality system processes by initiating and driving corrective and preventive actions. Identifies and proposes solutions to quality discrepancies and process improvements based on data collection, trend analysis and reporting activities. Must be able to communicate and follow-up on event description detail with internal and external customers in order to evaluate adverse event occurrences. Provides supports in the continuous improvement effort of the MSG quality system for processing complaints in order to meet FDA, ISO and all applicable international regulatory requirements, and corporate guidelines. Performs timely closure of product complaint files in accordance with established procedures. Requires general instruction for routine assignments from Manager or more experienced staff.

Job Duties

• Assist RA Analysts to conduct timely complaint and MDR investigations.

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  As needed, the RA Engineer I will communicate with customers and field personnel, and perform on-site visits.

• Perform complaint file closure in a timely manner.

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  Perform failure analysis and defect investigations.

• Interacts with complaint investigation teams to ensure investigation is completed in a timely manner.

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  Provide technical solutions to address and expedite product complaints.

• Communicates with Internal/External customers to identify details related to complaint information and occurrence.

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  Reviews associated complaint records to ensure the applicable assessment, investigation and analysis records are appropriate and complete.

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  Provide technical support to technicians, complaint administration staff and production shop floor staff relative to technical investigations.

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  Perform disposition of incoming complaints requiring an RA investigation in a timely manner.

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  Apply systemic problem solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

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  Work directly with the OEM to facilitate corrective and preventive action activities (CAPA) related to quality problems identified through complaint investigations and/or other sources of quality data.

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  Participate in process validation and New Product / Repair Introduction activities as needed.

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  As needed, provides specific complaint reports in database systems for the purpose of trend monitoring and/or complaint investigation and research assistance.

• Collects, summarizes and evaluates compliance performance metrics and works to identify improvement programs

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  Perform other related duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS:

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  A four-year degree in a technical discipline (e.g. EE, ME, BME, Microbiology, Chemistry, Quality Assurance), or equivalent knowledge.

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  Minimum of 1- 2 years experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries.

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  An entry level professional.

• General knowledge and application of technical and business concepts, procedures, and practices.

• Interprets company policies and procedures to resolve issues.

• Beginning knowledge of industry practices and standards.

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  Effective written and verbal communication skills.

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  Strong analytical, organizational, communication and interpersonal skills are required.

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  Computer literate with experience in Microsoft Office.

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  The anticipated compensation range for this position is 59,783.00 USD to 80,706.00 USD annually and the compensation offered will depend on the candidate’s qualifications.