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Quality Engineer

  • Anywhere

Company :
The Lubrizol Corporation

Location :
Milwaukee, Wisconsin

Expiry Date :
Sat, 17 Apr 2021 23:59:59 GMT

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Description :
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 Quality Systems Engineer is the process owner for different quality systems (CAPA program, customer complaints, nonconformance, internal and external audits, risk management and so forth). Responsibilities: 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. Qualifications: 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. With multiple facilities in and around Cleveland, Ohio, Lubrizol is in one of the largest economic regions in the United States. For the last seven years Lubrizol has been named one of the top workplaces in Northeast Ohio, and in 2016 was judged as the number one workplace by Northeast Ohio’s annual Top Workplaces survey. Buzzing with business, culture, knowledge and entertainment, Northeast Ohio is a vibrant place for people of all ages and walks of life to live, learn, work and play. This region offers a little bit of everything for everyone – ethnically-diverse communities, affordable housing, award-winning schools and universities, world-class healthcare, indoor waterparks and zoos, ski resorts, museums, halls of fame, one of the longest water-fronts in the country, and the most concentrated square mile of art, cultural, education and health institutions in the nation. From making your heart race at Cedar Point, to attending a professional sporting event or biking or hiking through over the 100,000 acres of state parks, to catching a Broadway show at Playhouse Square – the second largest performing arts center in the country, you can make it happen right here in Cleveland, Ohio.