Lead Quality Assurance Specialist

2 days ago

Rockville, Maryland, United States Meso Scale Discovery Full time
Job Summary

The Lead Quality Auditor will be responsible for the execution and documentation of the Quality Audits system/processes for the auditing of internal processes as well as external suppliers for MSD. This role will ensure the on-going compliance of MSD's Quality System to the company's active regulatory certifications, e.g. ISO 9001, ISO 13485, FDA regulations (as applicable).

Key Responsibilities
  • Maintain and execute the Supplier and Internal Audits audit program as per the published schedule with complete audits, timely reports, audit communications and audit follow-up and follow-through.
  • Ensure appropriate problem resolution methods are utilized and that verification of effectiveness has been completed.
  • Participate in the establishment of new suppliers for MSD.
  • Review customer questionnaires and provide QA input as required under guidance of supervisor.
  • Participate in supplier quality related communication and feedback.
  • Maintain the Approved Supplier List (ASL) and documented evidence of evaluation records.
  • Maintain on-going communication both inter and intra-departmental for status of projects, activities and audits.
  • Mentor and provide guidance to MSD staff participating in internal and/or external audits.
Requirements
  • Bachelor's degree in the sciences, engineering or health-related field required.
  • Minimum of 5 years of ISO or QSR auditing experience is required.
  • 3 years experience as a lead auditor in an ISO or QSR environment is strongly preferred.
  • Experience working with FDA and/or ISO auditors preferred.
  • Current ASQ certification (CQA, CQE) is strongly preferred.
Preferred Qualifications
  • Strong audit fundamentals and analytical background.
  • Logical problem-solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion.
  • Excellent oral, written communication and interpersonal skills.
  • Demonstrated ability to mentor in quality systems topics including ISO, QSR and auditing.
  • Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of audit data.
  • Proficiency in MS Office Suite.
  • Experience with standard data analysis tools (Visio, ERP and Project Management) and the quantitative background to advance this knowledge on the job is expected.
Work Environment

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office. Walk through MSD and supplier facilities as part of on-site audits and inspections. Up to 30% travel (air and car) required. Supplier site visits. Overnight hotel stays.

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