Quality Engineer II

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, NOM-241-SSA1, ASME Sección VIII division 1 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

1. Night shift availability
2. Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
3. Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis.
4. Initiate and/or participate in process and product corrective actions and problem-solving activities.
5. Update/establish documented work instructions as needed.
6. Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
7. Monitor and report on performance metrics.
8. Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
9. Collaborate with other departments and facilities within the company on quality related issues.
10. Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
11. Perform quality system audits and provide guidance on corrective actions.
12. Perform other duties as assigned
13. Compliance FDA and ISO 13485
14. Non-destructive testing (NDT) according to CSEI (AQSIQ)
15. ASME and PED code activities.

Specific Work Requirements (1-5 years)

1. Combined Manufacturing/Quality Engineering/Quality Systems experience or minimum of 6 months on-site STERIS internship or co-op experience.
2. Working in an ISO certified environment required.

Specific Work Preferences (1-5 years)

1. Medical device or other regulated industries experience preferred.
2. ASQ, QSR or familiarity with QSR/GMP regulations
3. Demonstrate experience leading or participating on improvement projects
4. Background on steel, mechanic assembly process
5. Knowledge on problem solving methodologies

Specific Skills and/or Business Competencies (1-5 years))

1. Excellent problem-solving skills
2. Focus on identification of potential issues and continuous improvement.
3. Experience working on cross-functional teams and on own initiative.
4. Demonstrated excellent organizational, oral and written communications skills.
5. Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
6. Experience with statistical analysis software and Visio preferred.

Education Degree