Quality Engineer

1 month ago

Portland, United States TALENT Software Services Full time

Are you an experienced Quality Engineer with a desire to excel? If so, then Talent Software Services may have the job for you Our client is seeking an experienced Quality Engineer to work in Arden Hill, MN.


Position Summary: Responsible for providing technical acumen and leadership to the Arden Hills Post Market Complaint Investigation Site (CIS) that directly supports complaint product investigations and signal escalations ranging from single-use devices to Capital Equipment and accessories within the Electrophysiology (EP) division. The team uses product performance data to investigate post-market field performance signals in collaboration with other post-market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety. The key focus is on understanding and developing product and process-specific improvements to increase rate of actionable outcomes of product investigations and improved use of Engineering Essentials and Problem-Solving Analytics to improve product performance in sustaining and future product lines. Will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC level. Responsible for identifying and implementing continuous improvements to improve product performance and complaint processes. This role provides significant visibility across the 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.
  • Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting 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.
  • Build Quality into all aspects of their work by maintaining compliance to all quality requirements.


Qualifications:

  • Bachelor's degree in engineering or other related technical/scientific discipline. FIRM.
  • A STEM degree, is desirable.
  • Recent grad with some coop/intern experience would be excellent.
  • or 1 year of related experience


Preferred:

  • Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards
  • Experience in the Medical Device industry or a Quality organization
  • Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
  • 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

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