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Quality Systems Specialist

Innovative Health LLC

Scottsdale, AZ

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JOB DETAILS
SKILLS
Bioengineering, Certified Internal Auditor (CIA), Communication Skills, Computer Skills, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Electrical Engineering, Environmental Management, Environmental Monitoring, External Audit, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Internal Audit, Maintain Compliance, Manufacturing Requirements, Mechanical Engineering, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Project, Microsoft Word, Multitasking, Presentation/Verbal Skills, Problem Solving Skills, Project/Program Coordination, Quality Assurance Methodology, Quality Control, Quality Engineering, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Risk Management, Root Cause Analysis, Team Player, Vendor/Supplier Evaluation, Writing Skills
LOCATION
Scottsdale, AZ
POSTED
4 days ago

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

About the Company

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Innovative Health LLC

Innovative Health introduces a targeted, high-impact Cardiology program to realize the largest possible savings from using reprocessed single-use devices. The Innovative Health team consists of the reprocessing pioneers who founded the industry. Innovative Health is the next generation in reprocessing, realizing optimal savings while reducing complexity.

COMPANY SIZE
50 to 99 employees
INDUSTRY
Medical Devices and Supplies
FOUNDED
2015
WEBSITE
http://www.innovative-health.com