Quality Engineer
Steris
- Montgomery, AL
- Permanent
- Full-time
- 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
- Bachelor's Degree in Engineering or related technical field, required.
- 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- 1-5 years of experience working in an ISO certified environment required.
- 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.
- 1-5 years of experience with medical device or other regulated industries, preferred.
- ASQ, QSR or familiarity with QSR/GMP regulations, preferred.
- Experience with statistical analysis software and Visio, preferred.
- Experience with ISO13485 strongly preferred.
- Strong experience with Quality Management Systems (QMS), preferred.
- Experience with Data Analytics, preferred.
- Understanding of blueprint drawings for raw materials / components, preferred.