Quality Systems Engineer

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;

Conduct 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.

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