Quality Engineer I

TALENT Software Services; Arden Hills (MN); On-site; USD 70,000 - 105,000; Full time

Job summary

TALENT Software Services is seeking a Quality Engineer to investigate product complaints and monitor post-market performance for a medical device portfolio in Arden Hills, MN. You will analyze data, conduct investigations, and collaborate across teams to mitigate risk and improve patient safety.

Responsibilities include reviewing lab analyses, leading CAPA-like activities, and communicating findings to management.

Qualifications

• Bachelor's degree in Electrical or Biomedical Engineering.
• BS with 1-3 years of relevant experience.
• Understanding and applying highly technical engineering topics and statistics.
• Ability to independently manage project work and meet delivery dates.
• Experience operating within quality system processes; strong communication and data analysis skills.
• Engineering degree with 2-3 years of relevant medical device experience.
• Experience in physical device analysis.
• Strong technical understanding of medical device therapy products.
• Participation in Hazard Analysis and Risk Assessment for trend management.
• Strong technical writing skills.
• Experience with quality system escalations, CAPA investigations and field assessments.
• Understanding regulatory requirements of post-market complaint tracking, trending and analysis.
• Project experience and collaboration with Medicalety, Design Assurance, Return Product Analysis, Supplier Development and Manufacturing.

Responsibilities

• Review 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 post-market product performance to management and design teams, supporting performance reports and customer requests.
• Providing input for process improvement and helping develop tactical approaches to team strategies.
• Perform data analysis for Product Performance and Risk Management documentation using statistical methods and software.
• Lead cross-functional project teams and manage timelines and resources.
• Adapt to changing responsibilities and new product lines as the department grows.
• Foster a diverse and inclusive workplace.
• 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.
• Review completed product analysis to ensure field allegations are addressed.

Skills

Data analysis

Statistical methods

Quality system knowledge

Communication (verbal & written)

Independent project management

Cross-functional collaboration

Education

Bachelor's degree in Electrical or Biomedical Engineering

Tools

Statistical analysis software

Job description

Description

About This Role: This quality engineer role will investigate product complaints and monitor BSC 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.

• Client-related assignment

Description

About This Role: This quality engineer role will investigate product complaints and monitor BSC 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.

• Client-related assignment

This role does not touch product.

Will be working with a team of 12. Very collaborative team.

Your Responsibilities may cr oss-functional BSC's Core Values of Caring, Meaningful Innovation, High Performance, Global Collaboration, Diversity, and Winning Spirit.

• 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 post-market 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; Identifies and leads cross-functional project teams comprised of functional experts and local managers.
• Open and flexible to change in responsibilities, taking on new engineering tasks and new product lines as the department grows and evolves.
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• 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.

Minimum Qualifications

• Bachelor's degree 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 solve problems collectively.
• Understanding and a command of highly technical engineering topics and applied statistics.
• Ability to independently manage project work to define and consistently meet delivery dates.
• Understanding and experience operating within quality system processes and procedures.Strengths in communication (verbal and written) and data analysis skills.

Preferred Qualifications

• 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.
• Strong understanding of the medical device regulatory requirements of post-market complaint tracking, trending and analysis.
• Project experience and/or collaboration with Medicalety, Design Assurance, Return Product Analysis, Supplier Development and Manufacturing.