Quality and Regulatory Manager

Lincotek, headquartered in Rubbiano, Parma, Italy, is a global contract manufacturer for services in markets including Industrial Gas Turbines, Aerospace and Medical Device applications, as well as a leading manufacturer of industrial coating equipment and one of the most respected producers in the Additive Manufacturing field. The Group has more than 1,800 employees located in 18 production facilities across Europe, North America and Asia.

Posizione

About The Job

The Quality and Regulatory Manager must possess experience in a manufacturing industry with increasing responsibilities in Quality Engineering and Regulatory Affairs. Strong focus on quality systems (e.g. ISO 13485, 21CFR 820) and on main Regulatory framework to obtain product approvals from foreign competent authorities (FDA, MDR,MDD,etc). Plans and oversees activities for product assurance program to prevent or eliminate defects in new or existing products by performing the following duties personally or with collaboration with other employees. Ensures the promotion of awareness of regulatory and customer requirements throughout the organization. Develop six sigma and lean thinking throughout the organization, Nonconformance and suppliers’ management, continuous improvement. He/she will be responsible for bringing new product and processes to market on time and within budget. He/she will apply techniques and processes, teach and mentor best practices (Lean, Six Sigma, Management System deployment DFM, DFA, DOE, FMEA, VA/VE, etc.).

He/she must possess strong experience in regulatory activities such as but not limited to: post marketing surveillance activities (FSN, FSA, Vigilance), clinical activities (elaborate data for clinical evaluation plan and report, PMCF plan and report, conduct literature research using database such as PubMed, Cochrane, Embase, Scopus) and CE marking activities. He/she will be responsible for bringing new product and processes to market on time.

Main Responsibilities

• Interface with Customer and Suppliers to govern any quality prescription of these relationships
• Develops and implements aspects for the company quality system.
• Works to improve and control regulatory/ISO compliance.
• Analyzes, evaluates, and presents information concerning factors, such as business situations, production capabilities, manufacturing problems, economic trends, and design and development of new and existing products.
• Develops document control.
• Suggests alternative methods and procedures in solving problems and meeting changing market opportunities.
• Establishes QA processes and is responsible for inspection of manufactured parts.
• Develops initial and subsequent modifications of product designs to delineate areas of responsibility, personnel requirements, and operational procedures within program, according to and consistent with company goals and policies.
• Devises sampling procedures and controls for continuous improvement of business processes.
• Evaluates contents of product assurance programs and confers with personnel preparatory to formulating product assurance program.
• Visits and confers with representatives of material and component vendors/customers 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.
• Compiles and writes training material and conducts training sessions on quality control activities.> [Not