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Quality Engineer, Manufacturing

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Company :
Medisafe International

Location :
Mentor, Ohio

Expiry Date :
Fri, 05 Feb 2021 23:59:59 GMT

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Description :
Job Title: Quality Engineer, Manufacturing Req ID: 21702 Job Category: Manufacturing Operations Country/Region: US State: OH City: Mentor Zip: 44060 Description: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary The Quality Engineer is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role supports operations production and process controls, product quality improvement, complaint/CAPA investigations with the use of statistical techniques and other accepted quality principles. This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. Duties * Participate on cross-functional new product development teams with focus on product quality and Quality System compliance. * Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis. * Initiate and/or participate in process and product corrective actions and problem-solving activities. * Update/establish documented work instructions as needed. * Review collected data to perform statistical analysis and recommend process/product changes to improve quality. * Monitor and report on performance metrics. * Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. * Collaborate with other departments and facilities within the company on quality related issues. * Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials. * Perform quality system audits and provide guidance on corrective actions. * Quality oversight of Third-Party Quality System requirements. * Perform other duties as assigned. Required Experience * Bachelor’s Degree in Engineering discipline required. Electrical Engineering degree highly preferred. * 2+ years of combined Manufacturing Quality Engineering and/or Quality Systems experience. * 2+ years of experience with medical device or other regulated industries prefered. * 2+ years of experience working in an ISO certified environment required. * Familiarity with Quality System Regulations and GMP regulations preferred. * ASQ Certified Quality Auditor preferred. What STERIS Offers The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans. Join us and help write our next chapter. #LI-KW1 STERIS is a $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries. If you need assistance completing the application process, please call 1 . This contact information is for accommodation inquiries only and cannot be used to check application status. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity. The full affirmative action program, absent the data metrics required by 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours. Nearest Major Market: Cleveland Nearest Secondary Market: Akron Job Segment: Quality Engineer, Industrial, Medical, Engineering, Manufacturing, Quality, Healthcare