Quality Systems Engineer - Innovative Health LLC

The Quality Systems Engineer 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.

Essential Duties and Responsibilities:

• Employ quality assurance methodologies in support of quality, engineering, manufacturing and regulatory functions;
• Responsible for leading the bi-monthly CAPA Review Board Meetings and leading root cause activities for CAPAs and other systems as needed;
• Responsible for coordinating site equipment calibration and preventive maintenance activities ensuring timely completion of tasks with appropriate documentation according to SOPs, work instructions, applicable standards, and guidelines;
• Provide direct communication with calibration service providers including coordinating and supervising onsite visits ensuring compliance with current requirements and standards;
• Review and approve calibration and preventive maintenance documentation;
• Support the eQMS Administrator with day-to-day activities processing workflows through Master Control software;
• Support Quality Management System processes such as, but not limited to, control of nonconforming product reports, product holds, deviations, etc.;
• Supports cross-functional company goals for Site Metrics;
• Assist in Risk Management activities, FMEAs and ensure compliance to standards and regulations;
• Develop procedures and practices to optimize product quality, safety, and reliability Participate in the failure investigation of product complaint and CAPA activities;
• Trend quality system metric data;
• Conducts internal and supplier audits along with assisting in preparation for external inspections/audits;
• Assist in Quality Control functions;
• Other tasks as assigned.

Education, Qualifications and Skills:

• Minimum of Bachelor's degree and minimum of 2 years of experience or equivalent experience is required;
• 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, 21CFR820, 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.