Quality Assurance Director

Indianapolis  ‐ Onsite
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Keywords

Description

The QA Director is an individual with extensive knowledge in quality systems and methodologies who can implement and maintain an FDA regulated QMS that complies with ISO 13485 as well as CMS/CLIA standards. Responsible for quality assurance activities related to clinical operations and IVD kit production process, associated upstream inputs.
  • Complete and strengthen QMS to ensure continued compliance, improved business practices, and mechanisms for improvements
  • Champion the ISO 13485 certification process
  • Facilitate process improvement teams to promote efficient utilization of resources
  • Ensure the site's process procedures, flow diagrams, FMEAs, and control plans are developed and maintained in accordance to procedures and regulations
  • Implement metrics for monitoring the effectiveness of the quality system
  • Utilize QA methodologies to standardize processes and to link product characteristics, process influences, and control strategies
  • Assess complaint, audit, and process data to determine corrective / preventive actions
  • Provide guidance on equipment, process, software, and test method validation requirements and design control activities for product and process development projects
  • Oversee Quality Management Review, internal audits, and material review
  • Facilitate audits (internal, supplier, 3rd party)
  • Harmonize Clinical Lab, R&D, Production, and Business quality practices and processes
REQUIREMENTS:

  • 8+ years in Medical Device or Pharma; 5+ years in production processes and quality systems
  • BS in Science/Engineering
  • 4+ years with 21 CFR Part 820, ISO 13485
  • Strong communication and relationship skills
  • Ability to balance compliance risk with business need
  • Open minded and collaborative spirit
  • 8-12 years of experience in a cGMP facility
  • CMS/CLIA/CAP experience highly desirable
  • IVD experience highly desirable
  • Ability to facilitate commercialization of FDA regulated product
Start date
06/2014
From
Real Staffing
Published at
06.06.2014
Project ID:
721986
Contract type
Permanent
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