Description:
About This Role:
This Quality Engineer role offers an employee the opportunity to be part of the Cardiac Rhythm Management Complaint Investigation Site within the Post-Market Quality Assurance team at ***. The primary activity for this role is to support analysis of investigations into field complaint allegations against *** products. This position is a vital part of improving patient care by ensuring *** device allegations are investigated efficiently and effectively.
Your Responsibilities Will Include:
"Assume a technical role within the Complaint Investigation Site by using technical expertise and knowledge to support current and new market released technology
"Assist Senior-level engineers in projects to enhance the ability to perform various complaint investigations
"Maintain knowledge of state-of-the-art principles and strategies in their particular area of expertise
"Participate in technical strategy planning for ***
"Assist Lab Technicians during complaint investigations to ensure accurate and compliant product analysis and documentation
"Review completed returned product analysis results to ensure field allegations are adequately addressed
"Analyze returned products to address complaints and to ensure a high level of product quality
"May be asked to engage in projects/project plans outlining work plans including timelines, roles, and resources; identify and lead cross-functional project teams comprised of functional experts and local managers
"Communicate product quality issues to Senior Engineers and/or Management for awareness to cross functional areas including Research and Development, Supplier Quality, and Manufacturing
"Participate in cross functional teams to resolve quality issues
"Interpret complex technical issues for a non-technical audience
"Provide technical support for regulatory and legal inquiries
"Assist in developing Client methods to effectively analyze product complaints
"Perform a variety of duties in the electrical, mechanical, electro-mechanical, chemical, or optical areas
"Support and/or perform Product Performance Engineering activities (trending, non-product return investigation analysis, etc.) during complaint investigation processing
"Respond to Technical Service Requests to support urgent questions from the Technical Service Team regarding product performance issues of devices being utilized in the field
"Serve as a support role for other activities within in the Complaint Investigation Site as needed
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Required Qualifications
"Bachelor of Science degree or higher in Engineering or related STEM field
"Understanding of technical engineering topics
"Ability to independently manage project work to define delivery dates
"Critical thinking, problem solving, and troubleshooting ability
"Strong communication (verbal and written) and data analysis skills
Preferred Qualifications
"Relevant experience in medical device industry or regulated environment
"Strong Technical Writing skills
"Experience working within a Quality System