Duration - 12 Months Contract (Possible Extension) 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 Client.
- The primary activity for this role is to support analysis of investigations into field complaint allegations against Client products.
- This position is a vital part of improving patient care by ensuring Client 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 Client
- 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 novel 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
Required Qualifications- Bachelor of Science degree or higher in Engineering or related STEM field
- Understanding of technical engineering topics
Preferred Qualifications- Relevant experience in medical device industry or regulated environment
- Strong Technical Writing skills
- Experience working within a Quality System
About US Tech Solutions:US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit
www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
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