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Innovative Health LLC
Quality Systems SpecialistInnovative Health LLC • Scottsdale, AZ, USA
Quality Systems Specialist

Quality Systems Specialist

Innovative Health LLC • Scottsdale, AZ, USA
30+ days ago
Job type
  • Full-time
  • Quick Apply
Job description

The Quality Systems Specialist role is responsible for supporting all areas of the pre-and post-market quality system activities; ensuring that the Quality System complies with FDA, ISO and customer requirements.

Role and Responsibilities:

  • Employ quality assurance methodologies in support of quality, engineering, manufacturing and regulatory functions
  • Responsible for the collection and management of environmental monitoring samples
  • Support Quality Management System processes such as, but not limited to, control of nonconforming product reports, product holds, deviations, etc.
  • Conduct internal and supplier audits
  • Assist in Risk Management activities, FMEAs and ensure compliance to standards and regulations
  • Investigation and management of customer complaints
  • Participate in the failure investigation of product complaint and CAPA activities
  • Lead root cause activities for CAPAs and other systems as needed
  • Trend quality system metric data
  • Assist in preparation for external inspections/audits
  • Review for completeness and adequacy of the Design History Files
  • Assist in Quality Control functions
  • Other tasks as assigned.

Qualifications:

  • Minimum of Bachelor's degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field) and minimum of 1 year of experience
  • Ability to work in a fast paced, collaborative team environment
  • Ability to handle multiple projects and coordinate cross functional teams
  • Knowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Good Manufacturing Practices (GMP) and applicable Quality System Standards
  • Certified internal/lead auditor is a plus
  • Able to use and demonstrate root cause analysis tools
  • Excellent verbal and written communication skills
  • Effective problem-solving skills
  • Ability to work in a team minded approach to achieve individual and company success
  • Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint and Microsoft Office Project programs
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Quality Systems Specialist • Scottsdale, AZ, USA

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