VP, Quality Management Systems

The VP, Quality Management Systems is responsible for establishing a Quality System and team that complies with FDA and ISO requirements, meets customer requirements, and positively impacts the company's financial performance. Champions continuous improvement efforts to establish an effective Quality System. Provides Quality leadership to all levels of the organization.

Role and Responsibilities:

Ensures the activities of all departments at the site remain in compliance with FDA, ISO, Quality System, and regulatory requirements;

Oversees CAPA processes, internal and supplier audits, customer complaints, documentation and training

Initiates and implements quality improvement activities as appropriate (e.g., Kaizen, Six Sigma) to raise the performance of the company's product lines;

Educates and trains employees as to their impact in the quality management system;

Serves as the primary quality control resource for problem identification, resolution, loss reporting and continuous improvement;

Leads internal audits and supports external audits, including ISO certification;

Performs root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements;

Establishes collection and analysis systems of statistical data to predict trends that will affect improvement of product quality;

Responsible for document control/change control and training activities (maintenance of training records, training matrix and competency matrix)

Initiates and implements strategies for international certifications and licenses

Initiates and implements quality improvement activities as appropriate (e.g., Kaizen, Six Sigma) to raise the performance of the company's product lines;

Educates and trains employees as to their impact in the quality management system;

Develops, implements, manages and integrates a QMS for manufacturing plants;

Manages Quality personnel daily;

Designs, implements and documents procedures for process control, process improvement, testing and inspection;

Establishes and implements metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions;

Reports to management on quality issues, trends and losses;

All other duties, as assigned.

Qualifications:

Bachelor's degree in mechanical engineering, electrical engineering, manufacturing engineering or business administration, or equivalent number of years of experience;

Fifteen (15) years of experience in Quality including ten (10) years of managing personnel;

Experience working with FDA and audit preparedness;

Regulatory Affairs background is preferred

Experience working in the medical device industry a must;

Experience with 21CFR820, Quality Systems Regulation and ISO 13485 a must.

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