Quality System Engineer

Hybrid Role (3 days a week)
Responsibilities:

• This role does not touch product.
• 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.
• 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
• Identifies and leads cross-functional project teams comprised of functional experts and local managers.
• Investigates and reviews electronic circuits and components.
• Analyzes returned products to address complaints.
• Assist Lab Technicians during complaint investigations to ensure accurate and compliant product analysis and documentation.
• Review completed product analysis to ensure field allegations are adequately addressed.

• Bachelor’s degree or higher in Electrical or Biomedical Engineering
• BS with 1-3 years of relevant experience.
• A strong desire to be a part of a team that looks to make a difference each day to collectively solve problems.
• Understanding and a command of highly technical engineering topics and applied statistics.
• Understanding and experience operating within quality system processes and procedures.

• Engineering Degree with 2-3 years of relevant medical device experience.
• Experience in physical device analysis.
• Strong technical understanding of medical device therapy products.
• Significant participation in the Hazard Analysis and Risk Assessment as related to trend management.
• Strong Technical Writing skills.
• Experience with the quality system escalations, CAPA investigations, and field assessments.