Quality Engineer - medical device

Quality Engineer - medical products company needs a longer term Quality Engineer to support plant manufacturing quality functions, process focus and process/machine validation.

  • Maintains process and software validation plans.  Writes process and or software validation protocols. 
  • Facilitates completion of validation activities, performs data analysis, and writes the validation report.  
  • Performs quality engineering reviews of design documentation for compliance with stated requirements.
  • Applies statistical analyzing of data to evaluate the current process and process changes. 
  • Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
  • Prepares reports to communicate involvement and results of quality assurance and quality engineering activities.
  • Maintains a working knowledge of FDA GMP and ISO 13485 standard

 

  • Education and/or Experience:                               
  • Bachelor's degree (B. S.) in engineering from a four-year college or university. Three to four-year related experience in qualify engineering.                          
  • To perform this job successfully, an individual should have working knowledge of Microsoft Office (Word, Excel, Access, PowerPoint).  
  • Requires knowledge of statistical techniques like Gage R&R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, and Sampling Plans.

Why Kelly®?

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we’re here every step of the way to find your dream engineering job.

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. 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.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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