pbLincotek, /bheadquartered 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. /ppPosizione: /ph3About The Job /h3pThe Quality Assurance Specialist is responsible for developing and maintaining the company’s Quality Management System (QMS). Working closely with Top Management, this role reports directly to the Site Quality Manager and collaborates cross-functionally across all plant departments. /ph3Main Responsibilities /h3ulliQMS Management: Maintain and manage the QMS to ensure all manufacturing processes and services supplied by Lincotek comply with regulatory standards and customer contractual requirements. /liliNon-Conformity CAPA: Manage Non-Conformity processes along with Corrective and Preventive Actions (CAPA). /liliDocumentation Compliance: Coordinate the preparation of quality documentation required for regulatory activities and certification audits, applying a risk-based approach across the entire QMS. /liliInternal Audits: Plan and execute internal audits. /liliSubcontractor Audits: Conduct audits at subcontractor facilities, including external laboratories. /liliTraining Program: Define and implement, in collaboration with Top Management, the quality training program for all personnel involved in activities impacting service quality. /liliCustomer Complaints Issue Resolution: Manage non-conformities, customer complaints, and preventive actions. /liliQuality Plans: Review, prepare, and approve quality plans with clients and suppliers of outsourced services/processes. /liliProcedures Instructions: Review and approve procedures and work instructions. /liliKPI Analysis: Manage KPI trend analysis to evaluate overall quality performance.



/liliContinuous Improvement: Identify quality issues or areas for improvement and propose effective solutions. /liliProduct Release: Define and implement product release flows (including issuing release documentation) in compliance with applicable medical device regulations. /liliScrap Defect Management: Define and manage workflows for scrap management and defect reporting, ensuring full compliance with medical standards. /li /ulh3SUPERVISORY RESPONSIBILITY /h3pnone /ppRequisiti: /ph3Education And/Or Experience /h3ulliBachelor’s degree in a scientific discipline (e.g., Physics, Chemistry, Engineering) or High School Diploma /liliat least 3 years of relevant experience /liliExcellent command of English and Italian (both written and spoken). /li /ulh3Skills /h3ulliTechnical Expertise: Solid background in laboratory analysis, non-destructive testing (NDT), sampling methodologies, metrology, and statistical data analysis. /liliRegulatory Knowledge: Knowledge of industry standards (ISO 13485, MDD 93/42, MDR 2017/745) is considered a plus /li /ulpAltre informazioni: /ph3WORK ENVIRONMENT /h3pThis job operates in both an office environment and a manufacturing environment. The role routinely uses standard office equipment, such as computes, phones, photocopiers, filing cabinets and fax machines. The individual will be required to adhere to safety policies and procedures on the manufacturing floor. /ph3POSITION TYPE/EXPECTED HOURS OF WORK /h3pThis is a full-time position, Monday through Friday 8am to 5pm, with additional hours as business needs necessitate. TRAVEL Occasional overseas and domestic travel may be required to support the rapid growth of the company. /ph3TRAVEL /h3pOccasional overseas and domestic travel may be required to support the rapid growth of the company. /ppLincotek provides equal employment opportunities 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. /p #J-18808-Ljbffr

📌 Quality Assurance Specialist (Busano)
🏢 Lincotek Group
📍 Busano