Quality Engineer

Quality Engineer I

Job Summary: Talent Software Services is in search of a Quality Engineer for a contract position in Arden Hill, MN. The opportunity will be eight months with a strong chance for a long-term extension.

Position Summary: This position is responsible for providing technical expertise and leadership at the Post Market Complaint Investigation Site (CIS). The role directly supports complaint product investigations and signal escalations, covering a range of products from Single Use Devices to Capital Equipment and accessories within the Peripheral Intervention/Vascular Surgery division. The team utilizes product performance data to investigate post-market field performance signals in collaboration with various departments, including Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety. The primary focus is on understanding and developing product and process-specific improvements to increase the rate of actionable outcomes from product investigations. This includes improved use of Engineering Essentials and Problem-Solving Analytics to enhance product performance in both sustaining and future product lines. The role involves identifying, coordinating, and executing project priorities based on business and department objectives, sometimes extending to a global level. The position is also responsible for identifying and implementing continuous improvements to enhance product performance and complaint processes, providing visibility across site and divisional leadership.

Primary Responsibilities/Accountabilities:

• Analyzing customer complaints, events, and other post-market surveillance data by examining the data for patterns and trends and investigating when necessary.
• Conducting product signal escalation analysis, investigation, and quality system documentation to identify performance improvement opportunities. This may include NCEP & CAPA ownership.
• Mentoring product investigators by providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques. Grow team utilization of investigative equipment (X-Ray, FTIR, SEM, etc.).
• Partnering with cross-functional teams to ensure the development and execution of streamlined, robust solutions to CIS processes are effectively implemented while still meeting organizational and regulatory requirements.
• Communicating product performance through formal presentations to management committees and design teams, supporting published product performance reports, and addressing customer requests for performance information either directly or through the sales organization.
• Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Post Market organizations.
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

Qualifications:

• Bachelor s degree in engineering or other related technical/scientific discipline (STEM-related degree is highly preferred and will move to the top of the candidate list).
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.

Preferred:

• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards.
• Experience in the Medical Device industry or a Quality organization.
• Ability to collaborate and influence across multiple, cross-functional teams.
• Knowledge of analytical techniques, problem-solving, continuous improvement programs, and statistical analysis.
• Self-starter with the ability to identify improvement opportunities.

If this job is a match for your background, we would be honored to receive your application!

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