Quality Systems Specialist

Quality Systems Specialist
Scottsdale, AZ
Posted 2 weeks ago

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

  • Employ quality assurance methodologies in support of engineering, manufacturing and regulatory functions;
  • Conduct internal and supplier audits;
  • Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications;
  • Assist in Risk Management activities, FMEAs and ensure compliance to standards and regulations;
  • Assist in managing 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 and conducting of regulatory agency inspections;
  • Review for completeness and adequacy of the Design History Files;
  • Other tasks as assigned.

Qualifications

  • Minimum of Bachelor’s degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field)
  • Thorough knowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards;
  • Certified internal/lead auditor
  • Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents;
  • Able to use and demonstrate root cause analysis tools
  • Understanding of sterilization validation and material biocompatibility requirements;
  • Understanding of software validation;
  • 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;
  • Demonstrated project management skills and experience;
  • Proficient in timely review of technical data;
  • Experience in device design control is preferred.

Job Features

Job CategoryQuality

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Misty Marshall

Misty Marshall


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