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Quality Engineer-Biomedical -Saint Paul, MN

Kelly Services
Saint Paul
55000.00 - 60000.00 USD Annual

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Job Type
Full Time
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**Quality Engineer-Biomedical**

**Saint Paul, MN**

**Schedule: 8am-5pm M-F**

**Pay rate: $55,000- $60,000/yr**


The Quality Engineer performs technical activities to ensure ongoing product compliance with the company's quality management systems and objectives. Responsibilities include supporting quality activities for all stages of product lifecycle and taking part in cross-functional teams to achieve company goals. The ideal candidate is a hands-on critical thinker that can operate independently to achieve shared team goals. This position is a part of the QA/RA team and reports to the Director of R&D and Regulatory Affairs.


+ Perform engineering studies; document process validations and verifications.

+ Assist with sterilization monitoring/revalidation, and environmental monitoring programs.

+ Assess nonconforming product for corrective and preventive action.

+ Perform and review root cause investigations; identify and implement corrective or preventive actions.

+ Identify trends in quality/compliance to enhance the product and/or QMS. Perform activities to maintain the effectiveness of the quality system.

+ Assist with equipment maintenance and calibration programs; assist with QMS software validations, as required.

+ Participate in hazard analysis and risk management, create FMEA documents.

+ Participate in internal audits.

+ Assess impacts of product changes. Participate in cross-functional development teams to provide product quality insight and feedback.

+ Assist in developing quality plans for new products.

+ Devise and implement methods and procedures for inspecting, testing and evaluating products or components.

+ Design or specify inspection and testing mechanisms and equipment; conduct QA tests.

+ Assist Quality Assurance, Manufacturing, or other functions as needed.

+ No vaccine requirement but if not vaccinated a mask is required at all times


+ Bachelor's degree in a scientific or technical discipline. Experience: 1+ years' experience within a regulated industry medical device experience preferred , or similar.

+ Experience with Quality Management Systems. Knowledge of ISO 13485 preferred. Experience with statistics or statistical process control concepts.

+ Experience with risk management/FMEA is a plus.

+ Good mechanical/technical aptitude.

+ Effective technical writing and communication skills; good organizational skills. Excellent attention to detail.

+ The ability to interface professionally and diplomatically throughout the organization is required.

Apply today!

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **??** **?**

Kelly?? Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** **??**

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ()

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