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Quality Assurance Engineer
2 months ago
Position Title:
Quality Assurance Engineer
Position ID:
Job Category:
Quality Assurance
At STERIS, we are dedicated to enhancing global health and safety through our innovative healthcare and life science solutions.
Role Overview:
The Quality Assurance Engineer plays a crucial role in upholding and enhancing the quality management system, ensuring compliance with relevant standards such as ISO 9001, ISO 13485, MDSAP, FDA regulations, and EU MDR.
This position involves supporting investigations related to complaints and corrective actions, enhancing supplier quality, overseeing production operations, and driving improvements in product and service quality through statistical methods and established quality principles.
Key Responsibilities:
1. Collaborate with cross-functional teams on new product development, focusing on quality assurance and compliance with the Quality Management System.
2. Design and implement statistically valid sampling plans, experimental designs, capability studies, and trend analyses.
3. Engage in corrective actions and problem-solving initiatives related to processes and products.
4. Update and establish documented procedures as necessary.
5. Analyze collected data to recommend improvements in processes and products to enhance quality.
6. Monitor and report on key performance indicators.
7. Educate colleagues on quality principles, effective corrective actions, and valid statistical techniques.
8. Work collaboratively with various departments on quality-related matters.
9. Ensure product integrity and quality by supporting the evaluation and management of nonconforming materials.
10. Conduct quality system audits and guide corrective actions.
11. Perform additional duties as assigned.
Qualifications:
• Bachelor's Degree in Engineering or a related technical field.
• 1-5 years of experience in Manufacturing/Quality Engineering and/or Quality Systems.
• 1-5 years of experience in an ISO certified environment is preferred.
Preferred Qualifications:
• Experience in medical device or regulated industries is advantageous.
• Familiarity with ASQ, QSR, or GMP regulations is a plus.
• Proficiency in statistical analysis software and Visio is preferred.
Skills:
• Strong problem-solving abilities with a focus on continuous improvement.
• Experience in cross-functional teamwork and independent initiative.
• Excellent organizational, verbal, and written communication skills.
• Proficient in PC applications, including Excel, Word, and PowerPoint.
Work Schedule:
This position is based on-site.
Company Overview:
STERIS is a leading global provider of products and services that support patient care, with a strong emphasis on infection prevention.
We are committed to equal employment opportunities and uphold affirmative action programs to ensure fair recruitment, hiring, training, and promotion practices.
