Job Title: Quality Engineer IV
Job ID: 19574-1
Location: Arden Hill, MN 55112
Duration:6 months
Pay Rate: $70.00 - $76.63/hr on W2
Required Qualifications
• Bachelor's degree in Engineering, Quality, Statistics, Life Sciences, or a related technical field.
• 7+ years of experience in medical device quality, post-market surveillance, complaint handling, complaint trending, reliability engineering, product performance monitoring, or a related field.
• Working knowledge of statistical concepts and their practical application to quality and product performance monitoring.
• Experience developing, evaluating, or maintaining complaint trending, monitoring, or signal detection methodologies.
• Strong Client Excel skills, including data manipulation, trend evaluation, and reporting.
• Demonstrated ability to apply technical judgment and risk-based thinking to solve complex problems.
• Strong written and verbal communication skills with the ability to document and explain technical rationale to diverse audiences.
Preferred Qualifications
• Experience within the medical device industry.
• Experience with complaint handling, post-market surveillance, or product performance monitoring programs.
• Knowledge of FDA post-market surveillance expectations, EU MDR PMS activities, or related quality system requirements.
• Experience participating in cross-functional reviews involving Quality, Regulatory Affairs, Clinical, Manufacturing, or Product Development.
• Experience developing technical reports, justifications, engineering assessments, or quality documentation.
• Familiarity with statistical process control, control charts, trend detection methodologies, or quality engineering techniques.