Quality Assurance Engineer
2 weeks ago
At STERIS, we are committed to enhancing global health and safety through our innovative healthcare and life science solutions.
About the Quality Assurance Engineer RoleThe Quality Assurance Engineer is essential in advancing and maintaining the quality management system in accordance with various standards such as ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other pertinent regulations. This role encompasses supporting complaint and corrective action investigations, improving supplier quality, overseeing operational production and process controls, and elevating product and service quality through statistical methods and established quality principles. The Quality Assurance Engineer is tasked with executing responsibilities related to the development, implementation, maintenance, and continuous improvement of quality systems at STERIS.
Key Responsibilities
- Engage in cross-functional teams focused on new product development, prioritizing product/service quality and adherence to Quality Systems standards.
- Design and implement statistically robust sampling plans, experiments, capability studies, SPC, and trend analysis.
- Lead or contribute to corrective actions and resolve process and product challenges.
- Update or create documented work instructions as required.
- Analyze gathered data and propose process/product improvements for enhanced quality.
- Monitor and report on performance metrics.
- Educate team members on quality principles, effective corrective actions, and valid statistical methods.
- Collaborate with various departments and facilities within the organization on quality-related issues.
- Ensure product integrity and quality through the assessment and management of nonconforming materials.
- Conduct quality system audits and provide recommendations for corrective actions.
- Perform additional duties as assigned.
- Bachelor's Degree in a relevant discipline.
- 1-5 years of combined experience in Manufacturing, Quality Engineering, or Quality Systems, or a minimum of 6 months of relevant internship or co-op experience.
- Preferred 1-5 years of experience in the medical device or other regulated sectors.
- 1-5 years of experience in an ISO certified environment.
- Certification from ASQ, QSR, or familiarity with QSR/GMP regulations is advantageous.
- Strong analytical and problem-solving skills.
- Proactive in identifying potential issues and driving continuous improvement initiatives.
- Experience in working collaboratively with cross-functional teams and demonstrating initiative independently.
- Excellent organizational and communication skills, both written and verbal.
- Proficient in PC applications, particularly Excel, Word, and PowerPoint.
- Preferably experienced in statistical analysis software and Visio.
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