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Lead Quality Auditor

2 months ago

Rockville, United States Meso Scale Diagnostics LLC Full time

POSITION SUMMARY:

The Lead Quality Auditor is 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. These audits are conducted to 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). Responsibilities will include providing support for implementation of corporate quality system improvements and mentoring of MSD internal and external auditors.

DUTIES AND 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. This will include but is not limited to:
    • Draft audit reports
    • Follow up and close audits
    • Monitor CAPA activities
    • Assist in answering questions and concerns generated from audits
    • Schedule follow up for corrective action responses
  • 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.
  • Other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor's degree in the sciences, engineering or health related field required. Bachelor's degree in other fields with additional years of relevant industry and work experience will be considered.
  • 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.

KNOWLEDGE, SKILLS AND ABILITIES:

  • 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.
  • Ability to multi-task and work productively in a demanding production environment with changing priorities.

PHYSICAL DEMANDS:

  • 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.

WORK ENVIRONMENT:

  • Standard office environment.
  • Up to 30% travel (air and car) required.
  • Supplier site visits.
  • Overnight hotel stays.

Qualifications

Education: Bachelors of Engineering (required)

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