2 openings for Quality Engineers. One is senior-level and the other is principal-level. Onsite positions for a top Medical Device company in Arden Hills, MN.
POST-MARKET COMPLAINT TRENDING ROLE
· BS (STEM) and 8+ years with Post-market Surveillance, Data Analytics and/or statistical analysis.
· Post-Market Surveillance
· Medical device experience
· Complaint Handling or Quality Engineering
· Power BI Dashboards
· Risk Management
· Understanding of Statistical Process Control (SPC) principles and methodologies.
· Experience performing statistical analyses and interpreting complex datasets.
· Knowledge of post-market surveillance and risk management principles.
· Experience supporting complaint trending, signal detection, or safety monitoring activities.
· Proficiency with Python and/or R.
· Experience with SQL and relational databases.
· Experience developing Power BI dashboards and data visualization tools.
· Knowledge of machine learning methods and practical applications preferred.
· Experience with process automation and analytical tool development preferred.
Required Education: Bachelor's degree in one of the following disciplines:
- Statistics
- Mathematics
- Computer Science
- Engineering
- Data Science
- Analytics or related technical field
Required Experience:
- 4-7 years of experience in data analytics, statistical analysis, quality engineering, post-market surveillance, or related field.
Key Responsibilities:
· Performs complaint monitoring, statistical trending, and signal evaluation activities to identify emerging product quality and patient safety concerns.
· Conducts signal assessments and presents findings, recommendations, and escalations to management review boards and cross-functional stakeholders.
· Develops, maintains, and improves complaint monitors aligned with risk management documentation, product hazards, and surveillance requirements.
· Executes ad hoc data analyses to support Quality, Regulatory, Clinical, Engineering, and business partner requests.
· Creates, maintains, and validates Power BI dashboards, visualizations, reports, and analytical tools.
· Applies statistical methodologies and Statistical Process Control (SPC) techniques to evaluate product performance and identify meaningful trends.
· Collaborates with Risk Management teams to ensure surveillance activities remain aligned with product risks and evolving post-market requirements.
· Supports continuous improvement initiatives through automation, data visualization, and process optimization efforts.
· Investigates data anomalies and develops recommendations to improve data quality, monitoring effectiveness, and signal detection capabilities.
· Communicates analytical findings to both technical and non-technical audiences through clear visualizations, presentations, and written summaries.
· Supports audit readiness and compliance with applicable quality system and regulatory requirements.
· Contributes to the development of innovative analytical approaches, including machine learning techniques, predictive analytics, and advanced statistical methodologies where appropriate.
Job Summary:
Develops, maintains, and continuously improves post-market surveillance and complaint trending methodologies, tools, and processes to support product quality, patient safety, and regulatory compliance. Performs statistical analyses, signal evaluations, and complaint monitoring activities to identify emerging risks and product performance trends. Partners with Quality, Regulatory, Clinical, Engineering, and Risk Management stakeholders to provide data-driven insights that support decision making across the product lifecycle.
Serves as a technical resource for post-market analytics, statistical process control, visualization development, and risk-based monitoring approaches. Supports the development and maintenance of analytical tools, dashboards, and automated solutions to enhance post-market surveillance effectiveness and efficiency.
Job Disclaimer:
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records.
#GRPC
Pay: $55.00 - $75.00 per hour
People with a criminal record are encouraged to apply
Work Location: In person
