Quality Systems Engineer
4 days ago
We are seeking a highly skilled Quality Systems Engineer to join our team at Integrated Resources. As a key member of our quality assurance department, you will be responsible for ensuring the highest level of quality in our products and processes.
Key Responsibilities:
- Critically review product and process Corrective and Preventive Actions (CAPAs) in various stages of the CAPA workflow
- Facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring
- Support updating the business processes relating to CAPA
- Perform timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving
- Project manage all aspects of CAPA activity which includes Producting the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines
- Support and prepare spokespersons in representing CAPAs during audits and CAPA Review Board meetings
- Lead and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques
- Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances
- Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available
- Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement
Requirements:
- Bachelor's degree in an engineering or scientific-related field or other plus equivalent technical experience working in a medical device environment
- At least 10 year's practical experience with CAPA
- Able to understand and analyze complex problems, including software and hardware design issues
- Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations
- Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971
- Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels
- Strong Project Management skills, including ability to project manage all CAPA activities
- Strong reasoning and logical thinking skills
- Excellent written and verbal communication skills in English
Estimated Salary: $120,000 - $150,000 per year, depending on experience
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