Quality Engineer/Post Market Specialist jobs in United States
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REQ Solutions ยท 3 hours ago

Quality Engineer/Post Market Specialist

REQ Solutions is seeking a Quality Engineer/Post Market Specialist to focus on data-related investigations of product complaints and performance. The role involves collaborating with cross-functional teams to enhance patient safety and product performance through data analysis and complaint investigations.

Outsourcing/Offshoring

Responsibilities

This role doesn't touch product - more data related
This role will investigate product complaints and monitor client product performance
The team uses product performance data and deep dive analysis to understand if products are performing as intended
Escalating post-market field performance signals to better understand what the data is telling us
Collaborating with cross functional teams to mitigate risk focusing on patient safety and improving product performance
Reviewing completed returned product lab analysis, customer feedback and historical data to identify proper coding for product complaints
Performing complaint investigations in accordance with local and global processes
Analyzing post market surveillance data for patterns and trends and investigating when necessary
May be responsible for querying & bounding data to support implementation of document releases
Responding to Competent Authority Requests
Communicating product performance by formal presentations to management committees and design teams
Supporting published product performance reports and customer requests for performance information either directly or through the sales organization
Providing input for process improvement and helping develop tactical approaches to implement team strategies
Perform data analysis for Product Performance and Risk Management documentation by applying statistical methods and software
May be asked to engage in projects/project plans outlining work plans including timelines, roles and resources

Qualification

Data analysisStatistical methodsQuality system processesTechnical engineering knowledgeCommunication skills

Required

BS with 1-3 years of relevant experience
Understanding and a command of highly technical engineering topics and applied statistics
Understanding and experience operating within quality system processes and procedures
Strengths in communication (verbal and written) and data analysis skills

Preferred

Candidates that thrive in this position include Biomed engineers, Math backgrounds, Chemical engineers

Company

REQ Solutions

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Funding

Current Stage
Growth Stage
Company data provided by crunchbase