Title: Quality Complaints Engineer I

Duration : 12 Months

Shift : First Shift|8-5

Description

• Trouble shooting
• Failure mode analysis
• CAPA
  Root Cause Analysis
• Non Conformances
• Reading and understanding engineering drawings
• Technical Writing
• Knowledge of Medical Device Regulation
• Understanding of GMPs (Good Manufacturing Practices) and GDPs (Good Documentation Practices).

Position Summary

The Engineer I, Quality Complaints will methodically process, and investigate, Medical Device customer feedback (complaints) in a high paced, efficient and accurate manner. The Engineer I will complete basic projects assigned by more experienced engineers and managers. They work on projects/matters of limited complexity in a support role while being closely managed.

Essential Duties & Responsibilities

• Methodically process, and investigate, Medical Device customer feedback (complaints) in a high paced, efficient and accurate manner
• Identify critical dimensions on component drawings and submit dimensional inspection requests
• Carry out basic standardized test methods and/or submit functional testing requests
• Establish and maintain communication both internal and external (with the customers and regulatory personnel as needed)
• Domestic and International Regulatory vigilance reporting is essential
• Write effective reports and do so in a timely, priority driven manner, working effectively in a team environment with shifting priorities and time sensitive requirements.
• References existing work to complete similar projects. Improves on previous work.
• Provides input to the product teams regarding the development of new designs, methods or processes.
• Works under supervision of more experienced engineers. Regular assignments are completed with minimum supervision.
• May assist in training new employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
• Work on special projects as they arise

Knowledge & Skills

• A willingness and capability to work with used, and therefore contaminated Medical Devices in a controlled setting
• Take in and communicate information effectively
• Communicate externally as needed, and do so in a professional manner
• Knowledge of Microsoft Word, Excel, and Outlook
• Has engineering foundation.
• Expected to spend majority of time learning and best practices.
• Has a basic understanding engineering discipline.
• Willingness to learn/understand big picture.
• Ability to complete projects with minimum supervision.
• Requires the ability to provide input and recommendations that impact the completion of project goals.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• Bachelor's degree from an accredited college or university (Engineering or Technology) required.
• 0-2 years experience
• Prior experience in quality assurance is preferred.
• Previous experience working in a regulated manufacturing or pharmaceutical/healthcare environment preferred but not required.

Work Environment

• This job operates in a professional office environment and routinely uses standard office equipment
• Work is performed in a safe environment.
• While performing the duties of this job, the employee is regularly required to work with contaminated Medical Devices in a controlled laboratory setting
• Must be able to occasionally move objects up to 15 lbs.