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Quality Engineer

Job Description

As a Quality Engineer, you will play a critical role in ensuring the quality, reliability, and compliance of products. This position focuses on handling product returns, complaint management, field servicing, and customer support, in addition to core quality engineering responsibilities.

Responsibilities

+ Oversee the process for product returns, including investigation, root cause analysis, and resolution of customer complaints. Ensure timely and accurate documentation and reporting in compliance with regulatory requirements.

+ Coordinate field service activities, including troubleshooting, repairs, and preventive maintenance.

+ Develop, implement, and maintain quality control systems and processes to ensure product compliance with FDA and other relevant regulations. Perform risk assessments, validation, and verification activities for medical devices.

+ Lead investigations into non-conformances and implement corrective and preventive actions (CAPA) to address quality issues and prevent recurrence.

+ Maintain accurate records for quality processes, including complaints, returns, and servicing activities. Support internal and external audits to ensure adherence to regulatory standards.

+ Identify opportunities to enhance product quality, streamline processes, and improve customer experience. Collaborate with cross-functional teams to drive quality initiatives.

Essential Skills

+ Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Quality Engineering, or a related field.

+ 3+ years of experience as a Quality Engineer in a regulated industry, preferably medical devices.

+ Experience in handling product returns, complaint management, and customer support.

+ Familiarity with field servicing and technical support for medical devices.

+ Experience with FDA regulations and other medical device quality standards.

+ Proficiency in quality tools and methodologies (e.g., FMEA, SPC, CAPA).

Pay and Benefits

The pay range for this position is $80000.00 - $100000.00/yr.

o Full Medical and Dentalo 401k o Stock optionso Annual bonus based on company revenueo PTO/Holiday Pay

Workplace Type

This is a fully onsite position in Saint Paul,MN.

Application Deadline

This position is anticipated to close on Sep 25, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.