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2202 Sr QA Auditor

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Newark/Princeton Area, NJ
$110,000 - $130,000
Job Type
Direct Hire
Jun 21, 2017
Job ID
Our client, a Fortune 150 Medical Diagnostics Equipment Manufacturer, is looking for a Senior QA Auditor to join Division Team in Central New Jersey area and independently conduct assigned audits to assess compliance to applicable business/division requirements, external standards/regulations and Corporate Quality System requirements across multiple Plants within Division.
  • Participate in audits of manufacturing and commercial affiliate US and Canada
  • Manage and/or participate in initiatives/projects that are cross functional/cross divisional in scope as Subject Matter Expert (e.g., due diligence, regulatory readiness, etc.) 
  • Be a technical expert in performance of cross-division audits.
  • Integrate regulatory, compliance, quality issues into audit and assessment planning processes, based on risk and ensure compliance to Regulatory, Division, Site and Corporate policies and procedures by promptly reporting non-compliance issues.  
  • Understand technical decisions that affect product quality.
  • Provide expertise audit support to the division in preparation for and during external audits.
  • Identify and communicate compliance issues and risks promptly so that they are understood.
  • Identify compliance risks against current standards/regulations and may guide in the planning and execution of Quality System improvements.
  • Provide guidance and train colleagues, provide oversight to one or more junior level auditors. and may assume managerial experience.
  • Utilize expertise and audit intelligence during audits.  Provide advice or recommendations for compliant and strategic solutions to complex quality issues.
  • Understand the risk and benefits of findings on the division(s) through engagement with the businesses and/or regions.
  • Demonstrate high proficiency in sterilization / aseptic processing, plastics and molding, IT or software quality assurance, good clinical practices.
  • Maintain and demonstrate understanding of global standards, regulations and regulatory bodies.
  • Develop management and supervisory skills through execution of managerial responsibilities as needed.

  • Bachelor degree in a technical area.
  • Minimum (5) years’ experience in FDA/CE regulated industry with medical device preferred
  • 3 years minimum required auditing experience or equivalent.
  • Ability to interpret and translate regulations into actions in a broad scope of activities across multiple divisions or regions.
  • Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; CFR 210/211, ISO 13485; IVDD; ISO 22000 etc.
  • Excellent written and verbal communication skills.  Personal skills needed, which include tact, open-mindedness, maturity, tenacity, decisiveness and sound judgment
  • Auditor Certification is a plus 
  • No sponsorship provided must be US Citizen or Permanent Resident