Senior Quality Assurance Engineer
2 weeks ago
At MillenniumSoft, we are seeking a highly skilled Sr. Quality Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality standards in our products and services.
Job Summary:The Sr. Quality Engineer will be responsible for evaluating and controlling product and service quality, working cross-functionally to develop and maintain products or services, and resolving equipment and process-related production issues. You will apply statistical analysis and metrics to analyze systems and processes, and demonstrate intermediate knowledge of quality engineering policies, principles, and best practices.
Key Responsibilities:- Evaluate and control product and service quality
- Work cross-functionally to develop and maintain products or services
- Resolve equipment and process-related production issues
- Apply statistical analysis and metrics to analyze systems and processes
- Demonstrate intermediate knowledge of quality engineering policies, principles, and best practices
- Sound workable knowledge and understanding of FDA 21 CFR 820 and ISO 9000:2015 and ISO 13485:2016
- Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis, and risk assessment
- Ability and skill to effectively manage multiple tasks and drive execution of change management plans
- Ability and skill to lead or manage process control, supplier quality, and continuous improvement projects using statistical techniques/tools
- Ability to effectively write communications that ensures clarity, accuracy, and consideration of the audience
- Ability to speak with clarity and express points of view in a variety of settings
- Ability to listen to others and make decisions and solve problems
- Experience with complaint investigation
- Professional certification preferred
- Experienced in Microsoft Office suite skills
- Certification such as ASQ-CQA/CQE, AAMI, Six Sigma, or a Company certification such as Green Belt, Black Belt, IGQA auditor
- BS in related field required with minimum of 3 years of Quality Operations or Regulatory experience in the medical device environment or 5 years in manufacturing environment or MS with 3 years of experience
At MillenniumSoft, we offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Sr. Quality Engineer looking for a new challenge, please submit your application today.
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