Quality Systems Specialist

Innovative Health LLC; Scottsdale (AZ); On-site; USD 70,000 - 90,000; Full time

Job summary

Innovative Health LLC in Scottsdale, Arizona, is looking for a Quality Systems Specialist responsible for supporting pre-and post-market quality system activities. This role ensures compliance with FDA, ISO, and customer requirements while employing quality assurance methodologies.

The ideal candidate will hold a Bachelor's degree in a technical field and have at least one year of experience. Responsibilities include conducting internal audits and managing environmental monitoring samples.

Qualifications

• Minimum of Bachelor's degree in a technical field.
• Minimum 1 year of experience in quality systems.
• Knowledge of ISO 13485 and Good Manufacturing Practices.

Responsibilities

• Employ quality assurance methodologies in support of quality functions.
• Conduct internal and supplier audits.
• Lead root cause activities for CAPAs.

Skills

Knowledge of FDA Quality System requirements

Excellent verbal and written communication skills

Effective problem-solving skills

Ability to work in a fast paced environment

Ability to coordinate cross functional teams

Root cause analysis tools

Education

Bachelor's degree in technical field

Tools

Microsoft Office Suite

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, ISO 14971, 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