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.
ResponsibilitiesOversee 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 SkillsBachelor’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).
Additional Skills & QualificationsFamiliarity with field servicing and technical support for medical devices is a plus.
Work Environment
You will be part of a quality team working with a Quality Manager and a Quality Technician. The role offers flexibility to focus on various aspects of quality such as QMS, design, and production. The position requires 2-5 years of experience, ideally from the medical device industry, but other industries will be considered. You will work on-site in Grand Ave, and cultural fit is crucial. The interview process includes a phone screen followed by an on-site interview. This is a fully on-site position.
Job Type & Location
This is a Permanent position based out of Saint Paul, Minnesota.
Pay and Benefits
The pay range for this position is $80000.00 - $100000.00/yr.
-\tClass I Device, they also sell a Class II disposable but do not manufacture it
-\tProjected to have $17M in revenue this year, growth up to $40M in 2026
-\tLooking to add a ME, QE, and Quality Technician due to doubling in size within the next year
-\tBrand new facility they moved into in July – 24,000 sqft
-\tBenefits Information:
o\tFull Medical and Dental
o\t401k (no company match at this point in time)
o\tStock options
o\t10% bonus (based on company revenue)
o\tPTO 3-4 weeks
o\t10ish holidays and 2-3 floaters per year
Workplace Type
This is a fully onsite position in Saint Paul,MN.
Application Deadline
This position is anticipated to close on Sep 19, 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 actalentaccommodation@actalentservices.com for other accommodation options.