Senior Quality Assurance Specialist

1 week ago


Baltimore, Maryland, United States MILLENNIUMSOFT Full time
Job Summary

MillenniumSoft is seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality engineering and a proven track record of ensuring product quality and compliance with regulatory requirements.

Key Responsibilities

Evaluate and control product and service quality
Work cross-functionally in the development and maintenance of products or services
Resolve equipment and process-related production issues
Conduct equipment, process, materials, and method validation
Apply statistical analysis and metrics to analyze systems and processes

Requirements

Sound knowledge and understanding of FDA 21 CFR 820 and ISO 9000:2015
Ability to analyze data using systematic analytical tools
Effective communication and project management skills
Experience with complaint investigation and quality audits
Professional certification such as Six Sigma or ASQ preferred

Preferred Qualifications

Bachelor's degree in a related field with a minimum of 3 years of quality operations or regulatory experience
Experience with electro-mechanical instrumented systems
Knowledge of regulatory requirements such as cGMP, FDA, and ISO

What We Offer

MillenniumSoft offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.

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