Quality Systems Engineer
STERIS Sharon Hill Permanent
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.
- Bachelor's Degree in Engineering General or Other
- 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.
- 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.
=== Company description
STERIS is a leading provider of infection prevention and procedural products and services, focused primarily on the critical markets of healthcare, pharmaceutical and research and medical devices. Our mission is to help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.We have 12,000 employees worldwide, with over 3,000 in Customer-facing sales and service roles. Founded as Innovative Medical Technologies in Ohio in 1985, the company was renamed STERIS in 1987. Many of the businesses that have been acquired and integrated into STERIS have much longer operating histories, notably the American Sterilizer Company founded in 1894.
The STERIS Vision is inspired by our Customers' efforts to create a healthier and safer world, and guided by our legacy of leadership and innovation; we strive to be a Great Company. To STERIS, this means we will make a difference by providing world-class product and service solutions for our Customers, safe and rewarding work for our People, and superior returns for our Shareholders.
STERISSharon Hill
certification (SPM, CPIM, CSCP) preferred.
• Experience in a lean manufacturing environment preferred.
Work Schedule
• This is a hybrid schedule opportunity based in Sharon Hill, PA.
• The schedule is: 3 days/week onsite, 2 days/week remote...
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