Quality System Manager

Job Description

Responsible for managing and controlling the Document Control activities through the EtQ Reliance System to ensure the effectiveness of the Quality Management System according to Medline's policies and procedures, as well as the requirements of ISO13485 and MDSAP. Support in the development and implementation of the QMS (ISO13485 and MDSAP) for MXC and MDC plants. Performs internal/external audits across all areas of the business. Ensure to coordintae customer complaints investigations and communicate them to Leadership Team . Lead and support quality projects improvements based on quality data trends. This position works along with the quality management team to ensure compliance of the quality system. This position requires a dynamic approach to customer with knowledge in quality systems in the manufacturing environment (ISO13485 and MDSAP).

Local ETQ Administrator • Manage all training groups within EtQ Reliance and report completion progress. • Manage SAP QA complaints Module. • Support in the compliance of all applicable requirements of the QMS (ISO13485 and MDSAP). • Support on implementation of the ISO13485 and MDSAP at MXC and MDC. • Manage and review of Quality procedures. • Notify and follow up with team members on customer complaints received and updates the customer complaint log. • Perform customer complaints investigations to come up with root cause and recommend actions. • Revise and evaluate key performance indicators and data trends by applying statistical methods for CAPA opening decision. • Coordinate CAPA's actions and implementation. • Generate and analyze trend reports for QA site management/division. • Participate on the QMS internal audit program as internal auditor

• Support on external audits received at the site as required. • monitoring process of the clean room and prepares results report. • Lead and support quality process improvement projects/CAPA • Manage the Quality Scorecard as required. •• Support in the planning and execution of the Quality activities. • Participate in the different programs of the organization as required.

EXPERIENCE: Bachelor's Degree Engineering Manufactured or related

Minimum 5-10 years of experience in Quality Systems Manager

Knowledge of ISO 13485 Standard and MDSAP Knowledge in Quality Systems

Audits Problem-Solving Skills

Fluently English Spoken

Others (Which ones?): Packdraw, SAP, Mpower, Munintra Office Windows: Word, Excel, Power Point, etc. Intermediate ETQ Reliance, AS400 Advanced

SKILLS : Communication, Organized, Teamwork, Responsible, Proactive Results Oriented, Sense of urgency

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.