Quality Engineer
- Nuevo Leon
- Permanente
- Tiempo completo
**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.
**Duties**:
- The Welding Quality Engineer is responsible of the none destructive test (NDT) per CSEI (AQSIQ) and additional to the previous duties, the primary job objectives include:
ASME and PED Code Activities
- Possess a thorough understanding of the ASME / PED / International Standards requirements for pressure vessels
- Assist & advise on training welding department personal as required on the ASME / PED / International Standards requirements (e.g. dye penetrant testing)
- Assist & approve production inspection checklists for pressure vessels per ASME / PED / International Standards requirements.
- Function as the designated Management Representative and assist in the internal ASME Code and individual country pressure vessel code audits and maintain formal files of all ASME / PED / International Standards audits.
Conduct external audits and/or source acceptance of raw material suppliers related to ASME / PED / International Standards requirements for pressure vessels.
**Duties - cont'd**:
**Required Experience**:
- 3-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- 3-5 years of experience with medical device or other regulated industries preferred.
- 3-5 years of experience working in an ISO certified environment required.
- ASQ, QSR or familiarity with QSR/GMP regulations preferred.
**Skills**:
- Bilingual 90%
- 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.
STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.
We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD.
STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.
STERIS strives to be an Equal Opportunity Employer.
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