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Quality Systems Engineer

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Date: Feb 11, 2021

Location: Franklin, WI, US, 53132

Company: Lubrizol Corporation

Vesta, part of Lubrizol LifeSciences, offers custom medical manufacturing services, including precision thermoplastic and silicone extrusion as well as comprehensive silicone fabrication from its ISO 13485 certified facilities. Vesta capitalizes on more than 40 years’ experience, leveraging expertise in design assistance, material selection and quality compliance to enable our customer’s success.

Vesta has served as a trusted medical device outsourcing partner for four decades, delivering innovative solutions in molding, extrusion and assembly. Our Franklin, Wisconsin location includes ISO 7 certified clean room, ISO 8 controlled environment, 116,000 ft2 (10,700 m2), 17 extruders with 12 lines, 75 molding presses and a dedicated R&D laboratory. Every one of our medical device manufacturing, assembly and support services has quality at its core. Our highly collaborative, end-to-end, medical device process validation ensures quality without sacrificing product performance.

POSITION SUMMARY:

The Quality Systems Engineer is primarily responsible for assuring Quality Systems quality compliance through the development, implementation, improving and monitoring of appropriate processes to meet quality/business metrics and goals.  Specifically, the Systems Engineer is the process owner for different quality systems (CAPA program, customer complaints, nonconformance, internal and external audits, risk management and so forth).

 

DESCRIPTION OF ESSENTIAL DUTIES:

  • Demonstrates critical thinking and problem-solving skills to address internal nonconformance, CAPA, customer complaints and continuous improvement project.
  • Ensures quality and business objectives are consistently met.
  • Facilitates cross-functional collaborations to drive projects to completion within the established timeline.
  • Benchmarks, improves and streamlines existing processes to achieve best-in-class status.
  • Acts as subject matter experts of responsible systems.
  • Leads continuous improvement activities (individual effort or cross-functional team).
  • Trends quality data and facilitates data review to detect potential issues.  
  • Hosts and participates in internal and external audits.
  • Provides detailed and timely follow-up with customer facing activities.
  • Maintains current knowledge of ISO 13485 and FDA QSR requirements and applies to applicable Vesta processes.

 

REQUIREMENTS:

  • Previous experience in medical device industry
  • Bachelor’s degree, preferably in a science or engineering-related discipline
  • Excellent written and verbal communication skills
  • Flexible to change with a high degree of integrity and “can do attitude”
  • Willing to work in a team environment and contribute to group goals
  • Ability to receive and provide feedback in a positive manner.
  • Computer skills, including Microsoft products

 

CONSIDERED A PLUS:

  • Knowledge of ISO 13485:2016, FDA 21 CFR Part 820
  • Experience with Statistical Process Control and Process Validation
  • Certified Quality Engineer or Auditor (ASQ)
  • Six Sigma Green or Black Belt
  • Strong technical writing skills applicable to the medical device industry or equivalent regulated industry

 

Interested in all the great benefits that Lubrizol has to offer? Click Here to Learn About all of Our Benefits!

 

Vesta is located in Franklin WI, a growing community of 35,000 people that is located in the Southeastern portion of Wisconsin, approximately 15 miles south of Milwaukee, WI and about 60 miles north of Chicago, Il.  The Southeastern portion of Wisconsin is bordered on the east by Lake Michigan, a Great Lake that has fantastic fishing and boating opportunities.  The City of Milwaukee is a diverse community with many ethnic festivals that occur almost every weekend from June until September.  Starting with the last week in June until the second weekend in July, the Henry Maier Festival Park, hosts Summerfest, one of the largest outdoor music festivals, highlighted by the Marcus Amphitheater, which hosts Main Stage concerts every evening.  Milwaukee is also the home to Harley Davidson, the Harley Museum and Harley Davidson Bike fest every 5 years.  If you are into professional sports, Milwaukee is home to the Milwaukee Brewers, who play at Miller Park, the Milwaukee Bucks  who are building a new area and the Green Bay Packers are within 2 hours driving distance from Milwaukee. 

 

Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law.

 

Do You Need Assistance?

Please let us know if you need an accommodation to proceed with your application for a posted job, or with any other aspect of the interview or assessment process.  You can either call 440-943-4200 and ask for Talent Acquisition or send an email to talentacquisition@lubrizol.com. Please note that this phone line and email address are not to be used for checking on the status of an already submitted application and not to be used by third party recruiters.


Nearest Major Market: Milwaukee

Job Segment: Quality Engineer, Manufacturing Engineer, Systems Engineer, Engineer, Engineering, Quality