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We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at STERIS Canada Corporation. As a key member of our quality team, you will be responsible for maintaining and improving our quality system in accordance with industry standards.
Key Responsibilities- Participate in cross-functional teams to develop and implement quality systems and processes.
- Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC, and trend analysis to ensure product quality.
- Initiate and participate in process and product corrective actions and problem-solving activities to address quality issues.
- Update and establish documented work instructions as needed to ensure compliance with quality standards.
- Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
- Monitor and report on performance metrics, including warranties, OOB, Installation and Manufacturing DPU, FPY analysis, to identify areas for improvement.
- Instruct other employees in quality principles, effective corrective actions, and valid statistical techniques to ensure a culture of quality.
- Collaborate with other departments and facilities within the company on quality-related issues to ensure consistency and compliance.
- Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
- Perform quality system audits and provide guidance on corrective actions to ensure compliance with industry standards.
- Address customer complaints and concerns in a timely and professional manner.
- Bachelor's Degree in a relevant field, such as Engineering or Quality Assurance.
- 5-7 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- 5-7 years of experience with medical device or other regulated industries preferred.
- 5-7 years of experience working in an ISO certified environment required.
- ASQ, QSR, or familiarity with QSR/GMP regulations preferred.
- Excellent problem-solving skills and ability to identify potential issues.
- Focus on continuous improvement and process optimization.
- Experience working on cross-functional teams and on own initiative.
- Demonstrated excellent organizational, oral, and written communication 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.
