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Quality Manager

Company: Aerotek
Location: Mesquite
Posted on: May 23, 2020

Job Description:

Site Quality Manager will have the responsibility to manage and monitor the quality activities of manufacturing and supplier operations. This position will support personnel to ensure the attainment of goals set for overall quality assurance/control systems, quality management systems and documentation, and overall quality reactive and proactive activities are met for the Dallas site. RESPONSIBILITIES * Plans, coordinates, and directs quality assurance programs and helps establish standards designed to ensure continuous production of products by performing duties. * Review and evaluate inputs related to the Quality Management System for compliance and trends * Directly supervise Quality Assurance Team * Manages department and overall expectations pertaining to setting accurate schedules, cost and resources * Establish and maintain policy for documentation of all products * Audits production facility to ensure compliance with applicable standards, ISO 9001/13485 QSR, and GMPs * Monitor and advise the performance of the site's quality management system, producing data, and measuring quality operations against set standards * Review products, processes and systems in an ongoing basis to determine where improvements can be made * Work with quality assurance and operations to establish procedures, standards, and systems * Work with purchasing, supplier quality and external suppliers to establish quality requirements for materials and components * Work with quality, operations and engineering to establish procedures, standards, and systems * Manage the selection and development of people, resources, and budgets necessary to perform the functions of the department * Trains workforce as required in various quality methods, standards and procedures * Ensure Quality system's effectiveness and conformance to industry standards Essential Qualifications: - Requires a Bachelor's degree (B.A/B.S) or minimum of eight years applicable/related experience in Wound Care, Medical Device Industry/OTC Drug and Cosmetic products - ISO 9001 and 13485, QSR, 21CFR820, 210 and 211 and cGMP knowledge Essential Experience: - Knowledge of Validation of Class 1/Class II Medical Devices/OTC Drug and Cosmetic products - Experience managing a large staff - Must have experience and knowledge of ISO 13485 and 9001 - Must have experience and knowledge of 21CFR820, 210 and 211 Additional Desirable Skills, Experience and Qualifications: - Self -motivated professional - Driven individual with a strategic, rigorous, persistent - Literate, numerate - Highly organized, diligent, structured About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing -- Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Keywords: Aerotek, Mesquite , Quality Manager, Executive , Mesquite, Texas

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