Regulatory Affairs and Quality Manager Regulatory Affairs and Quality Manager

Company Description 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 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 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. 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.
Establishes QA processes and is responsible for inspection of manufactured parts.
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.
Develops and implements methods and procedures for disposition of discrepant material, and devises methods to assess cost and responsibility.
Manage all Post Marketing surveillance activities (periodic update of PMS plan and report, PMS data elaboration, FSN/FSA management, Vigilance activities).
Develop, revise and maintain Clinical Evaluation Plans, Reports and PMCF documents for class III, IIb and IIa products, supporting the clinical data collection, performing clinical data research (literature, databases, studies protocols).
Prepare, review and maintain the technical documentation to support the MDR transition.
Adhere to the Company's Quality and Safety Management System and in accordance with its procedures and requirements.
Manage the QA and RA team (5 employees)
Bachelor's Degree in related field. or more than three years' related experience and/or training; Working Knowledge of the Quality System, appropriate regulations and standard
Good command of English, both written and spoken (B2/C1)
Proven experience in the Quality Engineering field with a minimum of 3 years in biomedical companies
Must have strong written and verbal communication skills, be able to read and write English fluently, and have the ability to interact with all levels of customers, supplier and competent authorities
Experience with literature research using database such as PubMed, Cochrane, Embase , Scopus
Ability to read , interpret and write technical documents
Experience with ERP systems, including quality Module, bill of materials, and work flow routing is preferred.
Position requires experience, initiative and the ability to work independently to produce the highest level of quality and productivity against established standards.Strong knowledge of Microsoft Office and Project and ERP. SAP experience preferred.
The individual will be required to adhere to safety policies and procedures on the manufacturing floor.
This is a full-time position, Monday through Friday 8.30pm, with additional hours as business needs necessitate.
TRAVEL:
Occasional overseas and domestic travel may be required to support the rapid growth of the company.
Lincotek providesequal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
#