Director of Quality

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Founded in 1984 and located in America’s heartland, this organization is a privately held, internationally recognized, full-service contract manufacturer specializing in medical and cosmetic products. While being ISO 13485:2003 certified, they offer product design, process design, hydrogel production, printing, manufacturing, and logistics. 

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Scope of Position:

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The Director of Quality will oversee all aspects of quality, championing the understanding that quality is both a system of documentation as well as fundamental in the way work is performed. This position will oversee all aspects of the quality system within the company, including, but not limited to, hosting regulatory and certification audits, performing root causes analysis on product quality issues, working with management on product recalls, working throughout the company on continuous improvement processes and providing oversight to the supplier / vendor quality processes.

 

Qualification and Experience:
 

• Bachelor’s degree in related area preferred.

• Statistical analysis, precision measurement, and process capability studies are an intricate part of the quality assurance program; therefore, formal education in courses related to these areas such as mathematics, statistics, and industrial practices are strongly desired for this position.

• Some quality assurance practices as they apply to individual unique products can be learned during on-the-job training, but overall capability in this discipline must be previously demonstrated.

• Minimum of five years of experience in a quality related supervisory or management role.

• Able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

 

Duties and Responsibilities:

 

• Designs and develops the quality objectives and activities of the company through direct reporting structure to the VP of Quality.

• Communicates and works together with other management within the company to maintain and improve the direction of the company.

• Develops and implements the quality assurance and quality control programs at Katecho to ensure conformity of processes to established quality standards.

• Assures that the internal quality system meets the requirements of ISO 13485, FDA Title 21 CFR Parts 11, 211, 820 etc., Canada MDD CANCMS, and Japanese Ministry of Health PDMR;

• Prepares for and represent the company as the designated management representative during all ISO 13485, FDA Title 21 CFR Parts 11, 211, 820 etc., Canada MDD CANCMS, and Japanese Ministry of Health PDMR and customer audits.

• Reports to management on the performance of the QMS and the avenues for improvement.

• Ensures the promotion of awareness of regulatory and customer requirements throughout the organization.

• Proactively works and communicates with all departments at Katecho in the area of quality with the goal of continuous improvement.

• Communicates with customers, vendors, quality representatives, and company personnel to discuss and resolve quality problems as required.

• Assures customer surveys are completed

• Responsible for Quality component of Supplier Scorecard

• Oversees the management of the customer complaint process.

• Ensure complaints are processed and investigated in a timely, accurate and efficient manner.

• Work with the customers to resolve the issues surrounding the complaints, and institute corrective and preventative actions resulting from the investigation of the complaint.

• Provides regulatory guidance with new product introductions.

• Over see management of the Quality Department(s) personel in the following areas: Staffing and Development and Training.

 

Please email a copy of your resume to blair.carter@searchrsa.com