Quality Engineer

Akkodis; Arden Hills (MN); On-site; USD 62,000 - 83,000; Full time

Job summary

Akkodis is seeking a Quality Engineer for Arden Hills, MN. This is a 12-month contract position focused on post-market surveillance, data analytics, and regulatory compliance in the medical device manufacturing sector.

The role requires developing and maintaining surveillance tools, performing SPC-based analyses, and delivering data-driven insights through dashboards (Power BI) to support product quality and patient safety across the lifecycle.

Qualifications

• 0–6 years of experience in data analytics, statistical analysis, quality engineering, or post-market surveillance.
• Experience applying SPC and data-driven insights across product lifecycle.
• Strong collaboration with cross-functional teams (Quality, Regulatory, Clinical, Engineering, Risk).

Responsibilities

• Develops, maintains, and improves post-market surveillance and complaint trending methodologies.
• Performs statistical analyses, signal evaluations, and complaint monitoring activities.
• Creates, maintains, and validates Power BI dashboards, visualizations, reports, and analytical tools.
• Communicates analytical findings to technical and non-technical audiences.
• Supports audit readiness and regulatory compliance.

Skills

Data analytics

Statistical analysis

Quality engineering

Post-market surveillance

Risk management

Education

Bachelor's degree in Analytics or related technical field

Tools

Power BI

Job description

Akkodis is Seeking a Quality Engineer For location of Arden Hills, MN. This is a 12-month contract Position. Ideally looking for a candidate with experience in medical device Manufacturing Industry

Pay Range: $45 - $60/hour; The rate may be negotiable based on experience, education, geographic location, and other factors

Your Responsibilities will Include:

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.

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Key Responsibilities

1. 1. Performs complaint monitoring, statistical trending, and signal evaluation activities to identify emerging product quality and patient safety concerns.


2. 2. Conducts signal assessments and presents findings, recommendations, and escalations to management review boards and cross-functional stakeholders.


3. 3. Develops, maintains, and improves complaint monitors aligned with risk management documentation, product hazards, and surveillance requirements.


4. 4. Executes ad hoc data analyses to support Quality, Regulatory, Clinical, Engineering, and business partner requests.


5. 5. Creates, maintains, and validates Power BI dashboards, visualizations, reports, and analytical tools.


6. 6. Applies statistical methodologies and Statistical Process Control (SPC) techniques to evaluate product performance and identify meaningful trends.


7. 7. Collaborates with Risk Management teams to ensure surveillance activities remain aligned with product risks and evolving post-market requirements.


8. 8. Supports continuous improvement initiatives through automation, data visualization, and process optimization efforts.


9. 9. Investigates data anomalies and develops recommendations to improve data quality, monitoring effectiveness, and signal detection capabilities.


10. 10. Communicates analytical findings to both technical and non-technical audiences through clear visualizations, presentations, and written summaries.


11. 11. Supports audit readiness and compliance with applicable quality system and regulatory requirements.


12. 12. Contributes to the development of innovative analytical approaches, including machine learning techniques, predictive analytics, and advanced statistical methodologies where appropriate.

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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.

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Qualifications

Required Education

Bachelor's degree in one of the following disciplines:

• Analytics or related technical field

Required Experience

• 0-6 years of experience in data analytics, statistical analysis, quality engineering, post-market surveillance, or related field.

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 the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

• medical


• dental


• vision


• life insurance


• short-term disability


• additional voluntary benefits


• an EAP program


• commuter benefits


• a 401K plan


• paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law


• Holiday pay where applicable

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

The Company will consider qualified applicants with arrest and conviction records in accordance with 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