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Lead Quality Assurance Specialist

2 months ago

Rockville, Maryland, United States Meso Scale Diagnostics LLC Full time
Job Summary

The Lead Quality Auditor is a critical role within Meso Scale Diagnostics LLC, responsible for ensuring the company's quality systems and processes meet regulatory requirements. This position requires a strong background in auditing and quality assurance, with the ability to lead and mentor internal and external auditors.

Key Responsibilities
  • Quality Audit Execution
    • Plan, execute, and document quality audits of internal processes and external suppliers.
    • Ensure compliance with regulatory certifications, such as ISO 9001 and ISO 13485.
  • Quality System Improvement
    • Support the implementation of corporate quality system improvements.
    • Mentor internal and external auditors on quality systems topics.
  • Supplier Management
    • Maintain and execute the Supplier and Internal Audits audit program.
    • Monitor CAPA activities and ensure problem resolution methods are utilized.
  • Communication and Collaboration
    • Participate in supplier quality-related communication and feedback.
    • Maintain on-going communication with internal stakeholders for status of projects and activities.
Requirements
  • Education
    • Bachelor's degree in a science, engineering, or health-related field.
  • Experience
    • Minimum of 5 years of ISO or QSR auditing experience.
    • 3 years' experience as a lead auditor in an ISO or QSR environment.
  • Certifications
    • Current ASQ certification (CQA, CQE) is strongly preferred.
Skills and Abilities
  • Strong Audit Fundamentals
    • Logical problem-solving and analytical background.
  • Excellent Communication Skills
    • Excellent oral, written communication, and interpersonal skills.
  • Leadership and Mentoring
    • Demonstrated ability to mentor in quality systems topics.
Work Environment
  • Standard office environment.
  • Up to 30% travel required.