Quality System Engineer

REQ Solutions; Saint Paul (MN); Hybrid; USD 70,000 - 90,000; Full time

Job summary

REQ Solutions is seeking an engineer specializing in post-market surveillance and product performance analysis. The role focuses on investigating complaints, monitoring device performance, and collaborating across teams to ensure safety and compliance.

Candidates should have an engineering degree and experience with quality systems and statistical analysis. The position emphasizes teamwork, data-driven decision making, and process improvements in a medical device context.

Qualifications

• Bachelor's degree in Electrical or Biomedical Engineering.
• Understanding of quality system processes and procedures.
• Experience with statistical methods and data analysis.
• Desire to work in a team solving problems daily.

Responsibilities

• Investigate product complaints and monitor client product performance.
• Analyze post-market surveillance data for patterns and trends.
• Collaborate with cross-functional teams to mitigate risk and improve product performance.
• Provide input for process improvement and team strategies.
• Review completed product analyses to ensure field allegations are addressed.
• Assist in complaint investigations to ensure accurate and compliant documentation.
• Respond to Competent Authority requests as needed.
• Lead cross-functional project teams on select initiatives.

Skills

Technical writing

Quality systems

Statistical analysis

Cross-functional collaboration

Education

Electrical or Biomedical Engineering degree

Job description

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.

Education/Experience:

• 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.

Preferred:

• 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.