Senior Quality Engineer

Akkodis; Arden Hills (MN); On-site; USD 55,000 - 112,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

Short-term disability

401K plan

Paid Sick Leave

Commuter benefits

Holiday pay

Paid leave as required by law

Job summary

Akkodis is seeking a Quality Engineer for a 12+ month contract in Arden Hills, MN. The role focuses on post-market analytics, complaint trending, and data-driven insights to support product quality and regulatory compliance.

Responsibilities include developing analytics tools, dashboards in Power BI, and applying SPC techniques to detect meaningful trends across the product lifecycle.

Qualifications

• Experience in statistical analysis and data interpretation.
• Background in post-market surveillance and quality engineering.
• Experience with data science methodologies.

Responsibilities

• Performs complaint monitoring, statistical trending, and signal evaluation.
• Develops and maintains complaint monitors aligned with risk management.
• Creates Power BI dashboards, visualizations, reports, and analytical tools.
• Applies statistical methodologies and SPC techniques to evaluate product performance.
• Collaborates with cross-functional teams to ensure surveillance activities.
• Supports audit readiness and regulatory compliance.

Skills

Statistical analysis

Post-market surveillance

Quality engineering

Data science

Education

Analytics or related technical field

Tools

Power BI

Job description

Akkodis is seeking a Quality Engineer for a 12+ months contract position with a client located in Arden Hills, MN.

Pay Range: $40/hr. - $81/hr. On W2 (The rate may be negotiable based on experience, education, geographic location, and other factors.)

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.

Responsibilities

1. Performs complaint monitoring, statistical trending, and signal evaluation activities to identify emerging product quality and patient safety concerns.
2. Conducts signal assessments and presents findings, recommendations, and escalations to management review boards and cross-functional stakeholders.
3. Develops, maintains, and improves complaint monitors aligned with risk management documentation, product hazards, and surveillance requirements.
4. Executes ad hoc data analyses to support Quality, Regulatory, Clinical, Engineering, and business partner requests.
5. Creates, maintains, and validates Power BI dashboards, visualizations, reports, and analytical tools.
6. Applies statistical methodologies and Statistical Process Control (SPC) techniques to evaluate product performance and identify meaningful trends.
7. Collaborates with Risk Management teams to ensure surveillance activities remain aligned with product risks and evolving post-market requirements.
8. Supports continuous improvement initiatives through automation, data visualization, and process optimization efforts.
9. Investigates data anomalies and develops recommendations to improve data quality, monitoring effectiveness, and signal detection capabilities.
10. Communicates analytical findings to both technical and non-technical audiences through clear visualizations, presentations, and written summaries.
11. Supports audit readiness and compliance with applicable quality system and regulatory requirements.
12. Contributes to the development of innovative analytical approaches, including machine learning techniques, predictive analytics, and advanced statistical methodologies where appropriate.

Quality Systems Duties and Responsibilities

Build Quality into all aspects of work by maintaining compliance with all quality system requirements, internal procedures, applicable regulations, and company standards.

Required Education

• Analytics or related technical field

Required Experience

• 3-8+ years of experience in statistical analysis, post-market surveillance, quality engineering, or data science.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan.

Our benefit offerings provide employees with the flexibility to choose the type of coverage that meets their individual needs.

Benefits

• medical
• dental
• vision
• life insurance
• short-term disability
• additional voluntary benefits
• an EAP program
• commuter benefits
• a 401K plan
• Paid Sick Leave
• any other paid leave required by Federal, State, or local law
• Holiday pay

Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

Candidate Privacy Information

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

EEO/Background

The Company will consider qualified applicants with arrest and conviction records by federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers