Quality Systems Specialist

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 Bachelors 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

Required Experience:

IC