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Quality Engineer II - United States  

Company managed [?] Still accepting applications
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Posted on : 04 April 2017

Project Description

Description:
  • As directed by the Quality Manager, the Quality Engineer II is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. 
  • This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.


Job Description
  • Moderate level application of technical principles, theories, concepts, techniques and quality sciences / tools.
  • Develops solutions to routine problems of moderate scope.
  • Follows company procedures and makes basic procedural updates.
  • Developing working knowledge of applicable regulatory, Corporate and/or Unit requirements.
  • Communicates across functions / departments for assigned areas of responsibility.
  • Is an extended team member representing Quality on new product development projects and a team member for sustaining engineering projects.
  • Provides audit support (preparation,  closure, etc. activities)


Position-Specific Overview:  
  • Position specific responsibilities include support of the following, however are not limited to:
  • Design Control  
  • Design Input
  • Design Output
  • Design Verification plans, protocols, and reports
  • Design Reviews
  • Design Validation
  • Design History File support
  • Change control
  • Assessment of Change Request (ACR) Responses
  • Risk Management
  • Process Validations
  • Identification of CTQ's
  • Unit Quality Independent Reviewer During Design Reviews
  • Handling of deviations and non-conformances
  • Test method validations
  • Supplier qualification
  • Software validations
  • Post Market Surveillance
  • Situation Analysis
  • CAPA – Root cause investigation and implementation of corrective / preventive actions
  • Proper Use of Statistics (Sampling Plans)
  • Advise on Regulations
  • Liaise with Manufacturing Plants
  • Provide functional support to cross-functional teams
  • Internal and external audits
  • Moderate knowledge of applicable regulatory, Corporate and / or Unit requirements.
  • Training in statistics.  Class II / III medical device experience (preferred).  Knowledge of design control principles (preferred).  
  • Ability to provide support to internal / external audits.
  • Typically requires a minimum of a Bachelor’s Degree
  • A minimum of 2 years relevant experience.