Senior Quality Assurance Engineer

2 weeks ago

Baltimore, Maryland, United States MILLENNIUMSOFT Full time
Job Title: Sr. Quality Engineer

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
Requirements:
  • 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
Preferred Qualifications:
  • 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
What We Offer:

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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