Quality Engineer - Arden Hills, MN (Hybrid)

Analyzes product performance and post-market surveillance data to develop, maintain, and continuously improve complaint monitoring strategies. Applies statistical concepts, product knowledge, risk-based decision making, and cross-functional collaboration to establish appropriate product complaint trending criteria and document supporting rationale. Partners with quality, clinical, regulatory, manufacturing, and engineering stakeholders to ensure monitoring approaches remain effective, compliant, and aligned with product risk profiles throughout the product lifecycle.

Key Responsibilities
• Leads or supports projects focused on developing, maintaining, and improving product complaint monitoring strategies and criteria.
• Evaluates complaint data, product risk profiles, lifecycle characteristics, and usage patterns to determine appropriate monitoring methods and thresholds.
• Develops, documents, and defends the rationale for product-specific trending criteria using statistical principles and engineering judgment.
• Partners with cross-functional stakeholders including Product Development, Manufacturing, Clinical, Regulatory, Quality, and Complaint Investigation teams to ensure monitoring approaches remain appropriate and effective.
• Reviews and periodically reassesses existing monitoring strategies to ensure they remain aligned with product performance, risk, and regulatory requirements.
• Performs complaint trending analyses and investigates potential signals, anomalies, or emerging product performance concerns when identified.
• Documents technical justifications, monitoring decisions, peer reviews, and supporting evidence in accordance with quality system requirements.
• Supports implementation and continuous improvement of complaint monitoring processes, work instructions, and best practices.
• Uses Excel and other available tools to evaluate complaint and product performance data, generate supporting analyses, and maintain documentation.
• Participates in audits, inspections, and quality system activities related to complaint monitoring and post-market surveillance processes.
• Acts as a technical resource for complaint trending methodologies, monitoring criteria development, and post-market performance evaluation.
• May mentor less experienced employees and lead cross-functional initiatives related to complaint monitoring and signal detection.

Desired Skills
• Statistical reasoning and application of basic-to-intermediate statistical methods
• Product complaint trending and signal detection
• Technical writing and rationale documentation
• Cross-functional collaboration and stakeholder engagement
• Problem solving and critical thinking
• Project management and organization
• Advanced Microsoft Excel

Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Job Requirements
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 Microsoft 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.

 

P:  +1 321-425-1876