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.
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.
* Develops and implements methods and procedures for disposition of discrepant material, and devises methods to assess cost and responsibility.
* Develop Six Sigma and Lean Thinking throughout the organization.
* 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.
* Manage the extra EU registration.
* Interface with all areas of the company, on technical documentation preparation for CE marking process.
* Adhere to the Company's Quality and Safety Management System and in accordance with its procedures and requirements.
* Perform other duties as assigned.
SUPERVISORY RESPONSIBILITY:
Manage the QA and RA team (5 employees)
EDUCATION AND/OR EXPERIENCE:
* Bachelor's Degree in related field. Prefer a Master's degree (M. A.) or equivalent; or more than three years’ related experience and/or training; or equivalent combination of education and experience.
* Working Knowledge of the Quality System, appropriate regulations and standard
* Knowledge of 2017/745 Regulation (MDR), MDCG, MEDDEV, NBOG guidances, FDA guidances and submission process (510k, PMA,DeNovo)
* Familiarity with ISO 10993, ISO 14971, ISO 13485.
* Good command of English, both written and spoken (B2/C1)
SKILLS:
* 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. Self-motivated and multi-task oriented.
* Strong knowledge of Microsoft Office and Project and ERP. SAP experience preferred.
* Attention to detail with the ability to recognize discrepancies.
WORK ENVIRONMENT:
This job operates in both an office environment and a manufacturing environment. The role routinely uses standard office equipment. The individual will be required to adhere to safety policies and procedures on the manufacturing floor.
PHYSICAL DEMAND:
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, use hands to finger, handle or feel and reach with hands and arms.
POSITION TYPE/EXPECTED HOURS OF WORK:
This is a full-time position, Monday through Friday 8.30am to 5.30pm, 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 provides equal 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.