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 standards such as iso 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 using statistical techniques and accepted quality principles. The role involves activities related to the development, implementation, maintenance, and continuous improvement of steris quality systems.
duties
1. participate in cross-functional new product development teams focusing on product/service quality and quality system compliance.
2. develop and implement statistically valid sampling plans, designed experiments, capability studies, spc, and trend analysis.
3. initiate and participate in process and product corrective actions and problem-solving activities.
4. update or establish documented work instructions as needed.
5. review data to perform statistical analysis and recommend process/product changes for quality improvement.
6. monitor and report performance metrics such as warranties, oob, installation and manufacturing dpu, fpy analysis, and develop action plans to improve kpis.
7. instruct other employees in quality principles, effective corrective actions, and statistical techniques.
8. collaborate with other departments and facilities on quality issues.
9. maintain product integrity and quality through evaluation and disposition of nonconforming materials.
10. perform quality system audits and guide corrective actions.
11. handle customer complaints.
12. the welding quality engineer is responsible for nondestructive testing (ndt) per csei (aqsiq) and related duties, including:
* asme and ped code activities
* understanding of asme/ped/international standards for pressure vessels
1. participate in safety, continuous improvement, and training initiatives, including a3 certification, stop observations, safety audits, kpi management, cip projects, and system upgrades.
2. maintain and improve the quality system per standards such as iso 9001, iso 13485, mdsap, fda 21 cfr part 820/211, eu mdr, nom-241-ssa1, and others.
education
* bachelor's degree in engineering or related field.
required experience
* 5-7 years in manufacturing/quality engineering or quality systems.
* experience with medical devices or regulated industries preferred.
* experience working in an iso-certified environment required.
* familiarity with qsr/gmp regulations and certifications like asq preferred.
skills
* bilingual proficiency (90%)
* strong problem-solving skills
* focus on issue identification and continuous improvement
* experience in cross-functional teamwork and independent work
* excellent organizational and communication skills
* proficiency with pc, excel, word, powerpoint, and statistical software; visio preferred.
steris is a leading global provider supporting patient care with infection prevention products and services. We are committed to creating a healthier and safer world through innovative healthcare, life sciences, and dental solutions. As a $5 billion, nyse-traded company with approximately 17,000 employees, we serve customers in over 100 countries.
steris is an equal opportunity employer.
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