- Develops, implements and coordinates product assurance program
- Prevent or eliminate defects in new or existing products
Sobre nuestro cliente
International manufacturer of medical devices.
The main responsibilities are to:
- Responsible for managing customer audits and regulatory/compliance agency audits. Carry out validations of the CFR agreement part 820. Validation protocols, IQ, OQ, PQ, and maintains the requirements of ISO 13485.
- Analyzes, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of management team
- Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities
- Cooperates with other top management personnel in formulating and establishing company policies, operating procedures and goals.
- Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements and operational procedures within program.
- Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program.
- Conducts management meetings with product assurance program department heads to establish, delineate and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.
- Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
- Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders and vendor quality standards.
- Confers with engineers about quality assurance of new products designed and manufactured products on market to rectify problems.
- Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry.
Perfil buscado (Hombre / Mujer)
BS in Engineering. 5+ years of experience in Quality department in global medical manufacturing companies. Demonstrated knowledge in FDA regulations such as ISO 13485 and CFR 820 and wide experience in customer quality assurance. ASQ certification and advanced English are a must.
Attractive compensation package plus benefits above the law.