Quality Engineer I

Quality Engineer

Location: Arden Hills, MN

Job Type: Hybrid Contract Position

Schedule: Hybrid - Onsite Tuesday, Wednesday, and Thursday

Pay Rate: $ 37.00/hour

Shift: Monday-Friday, 8:00 AM - 4:30 PM

Position Overview

We are seeking a Quality Engineer to support product performance investigations, complaint analysis, and post-market quality activities for a medical device organization in Arden Hills, MN. This hybrid role focuses on evaluating product complaints, analyzing returned product data, identifying performance trends, and collaborating with cross-functional teams to support patient safety and continuous product improvement.

The ideal candidate will have an electrical or biomedical engineering background, strong analytical skills, and experience working within regulated quality systems.

Key Responsibilities

• Investigate product complaints and evaluate product performance data to identify trends, risks, and opportunities for improvement.

• Review returned product laboratory analysis, customer feedback, and historical data to support accurate complaint documentation and coding.

• Perform complaint investigations in accordance with established quality system processes and procedures.

• Analyze post-market surveillance data to identify patterns and investigate potential product performance concerns.

• Collaborate with engineering, manufacturing, quality, and other cross-functional teams to develop effective solutions.

• Assist laboratory technicians during complaint investigations to ensure accurate product analysis and compliant documentation.

• Review completed product analysis reports to verify field concerns are adequately addressed.

• Perform data analysis using statistical methods and software to support risk management and product performance documentation.

• Support quality escalations, CAPA investigations, and field performance assessments.

• Prepare technical reports, presentations, and documentation for leadership teams and engineering groups.

• Participate in cross-functional projects by developing project plans, tracking timelines, and coordinating resources.

• Investigate electronic circuits and components as part of product evaluations.

• Contribute to process improvements and support evolving engineering initiatives.

Required Qualifications

• Bachelor's degree or higher in Electrical Engineering, Biomedical Engineering, or related engineering discipline .

• 1-3 years of relevant engineering experience.

• Strong electrical engineering background required.

• Experience working within quality systems, procedures, and regulated environments.

• Ability to understand and apply technical engineering concepts.

• Strong analytical, problem-solving, and data interpretation skills.

• Excellent written and verbal communication abilities.

• Ability to independently manage projects and meet deadlines.

• Must be authorized to work in the U.S. without current or future visa sponsorship.

Preferred Qualifications

• Experience within the medical device or regulated manufacturing industry.

• Experience with product complaint investigations and returned product analysis.

• Knowledge of post-market surveillance, complaint trending, and regulatory quality requirements.

• Experience supporting CAPA investigations and risk management activities.

• Familiarity with hazard analysis and risk assessment processes.

• Strong technical writing and documentation skills.

• Experience collaborating with Design Assurance, Manufacturing, Supplier Quality, Medical Safety, and Engineering teams.

• Knowledge of medical device products and performance evaluation.

Why Join This Opportunity?

• Competitive pay rate of $ 37.00/hour

• Hybrid work schedule with three onsite days per week

• Opportunity to support innovative medical device quality initiatives

• Collaborative engineering and quality-focused environment

• Hands-on experience with complaint investigation, risk management, and product performance analysis

If you are a detail-oriented engineer with a passion for quality, problem-solving, and improving product performance, we encourage you to apply.

Pay Details: $37.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, 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.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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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

• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.