Regulatory Compliance Auditor in Bothell, WA at Volt

Date Posted: 2/19/2021

Job Snapshot

  • Employee Type:
    Direct Hire
  • Location:
    Bothell, WA
  • Duration:
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch
  • Phone

Job Description

VOLT is seeking candidates for "Regulatory Compliance Auditor" role for our client in Bothell, WA. This is a Direct Hire role. 

Candidate needs to work from Bothell, WA location. Some relocation assistance will be provided.


Internal and External Audit Experience

Medical Device Industry experience

Experience with MDSAP Audits

Job Description:

  • Support the performance of internal audits to determine compliance with Quality Management System standards, policies, and procedures, as well as regulatory and customer requirements.
  • Conduct and/or oversee and assist in conducting audits, generating reports, recommending corrective action plans, and verifying implementation effectiveness of QMS corrective and preventive actions for both internal, distributor, and software vendor audits.
  • Prepare and/or lead regulatory assessments following established procedures; and prepare appropriate reports of audit findings to audited parties and management representatives.
  • Execute to the Internal Audit schedule, Distributor Audit Schedule, and Software Vendor Audit Schedule.  Support audits, monitor execution, and ensure timely completion of observation response and action items.
  • Support Director in developing auditor-training programs for internal, supplier, and external audit management.
  • Support Director in the execution and distribution of standard metric reports, preparation of compliance input for management reviews, maintain company compliance scorecard, and related documentation.
  • Maintain configuration of electronic Quality Management Software (eQMS) Audit module.
  • Provide support in the management, Regulatory Authority reporting, and tracking of Field Corrective Actions.
  • This role will require the ability to work autonomously on specific compliance activities including projects and based business tasks, both planned and unplanned with accelerated timelines; other duties as assigned.

Knowledge, Skills, and Abilities:

  • Bachelor’s Degree in a Scientific or Engineering field required.
  • A minimum of 5 years’ experience in compliance and/or quality system activities in a QSR/13485 Quality Management System and MDSAP audits.
  • Knowledge of the following regulatory requirements is required: GMPs, MDD / MDR, CMDR, TGA, ANVISA, PMDA.
  • Proven track record of successfully supporting external audits (such as FDA, Notified Body, or customer audits) required. Front and backroom support preferred.
  • Demonstrated knowledge, understanding or application of audit principles, concepts and practices related to a regulated quality system.  Able to collaborate effectively with employees of various disciplines and departments.
  • The ability to complete regulatory reports and provide written correspondence to internal and external customers including regulatory bodies. 
  • Must have the ability to handle confidential data.
  • Lead Auditor or ASQ Certification (e.g. Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), etc.) or equivalent work experience required.
  • Must be a critical thinker, detailed oriented with strong problem-solving skills, able to oversee multiple tasks for several projects or base business deliverables, and effectively balance priorities.

VOLT is an Equal Opportunity Employer