Job Description
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