Quality Systems Engineer

Quality Systems Engineer Req ID: 45358 Job Category: Quality Location: Sharon Hill, PA, US, 19079 Workplace Type: Onsite 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 complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement 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/ service 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. Executes environmental monitoring process and record keeping Participate on a Material Review Board Perform other duties as assigned. Education Degree Bachelor's Degree in Engineering General or Other Required Experience 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience. 1-5 years of experience with medical device or other regulated industries preferred. 1-5 years of experience working in an ISO certified environment required. ASQ, QSR or familiarity with QSR/GMP regulations preferred. #LI-BN1 Skills Excellent problem-solving skills Focus on identification of potential issues and continuous improvement. Experience working on cross-functional teams and on own initiative. Demonstrated excellent organizational, oral and written communications skills. Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint. Experience with statistical analysis software and Visio preferred. STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries. If you need assistance completing the application process, please call 1 (440) 392.7047. 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. Req ID: 45358 Job Category: Quality Location: Sharon Hill, PA, US, 19079 Workplace Type: Onsite STERIS Sustainability Life at STERIS Nearest Major Market: Philadelphia Job Segment: Systems Engineer, Medical Device Engineer, Quality Engineer, Infection Control, Manufacturing Engineer, Engineering, Healthcare

Created: 2024-11-05