21 ago - Granarolo dell'Emilia
Lincotek Group
**About the role** The Quality Control Senior Supervisor is responsible for managing and overseeing all activities related to the inspection of raw materials, semi-finished, and finished products during manufacturing and final release phases, ensuring compliance with required quality standards in accordance with technical specifications, regulatory requirements, and internal procedures. This role leads a team and ensures the effectiveness of incoming, in-process, dimensional, functional, and quality controls, guaranteeing compliance of manufactured medical devices with applicable standards, including both implantable devices and surgical instruments. The position is also responsible for managing inspection and measurement equipment, ensuring proper selection, qualification, calibration, maintenance, and suitability for intended use, in compliance with Quality System requirements and applicable regulations. It ensures measurement traceability and proper calibration record management, guaranteeing that all equipment is used under controlled and appropriate conditions. **Posizione**:
**Main Responsibilities** Team Management Lead, manage, and supervise the Quality Control team (7 direct reports) Plan activities, shifts, and operational priorities Promote a Quality culture focused on continuous improvement Quality Control Define and optimize incoming and in-process quality control plans Establish sampling plans and statistical rationale in line with customer specifications and applicable standards Coordinate and supervise: Incoming inspections (raw materials, components, semi-finished goods) Dimensional and functional checks (using metrology tools such as calipers, micrometers, CMM)
Quality inspections on semi-finished and finished products Ensure compliance with technical specifications and regulatory requirements Advanced Metrology & CMM Program and optimize Coordinate Measuring Machines (CMM) Define measurement strategies and automated inspection cycles Validate measurement methods ensuring repeatability and accuracy Support the team in advanced CMM usage Statistical Analysis & Data Management Analyze data and produce process performance reports Support capability studies and process validation activities Technical Interpretation Interpret technical drawings and product specifications at an advanced level Collaborate with Engineering, Quality Assurance, and Production in case of deviations, concessions, and technical clarifications Deviation, Non-Conformity & CAPA Management Collaborate with Engineering and Quality Assurance in managing internal deviations and non-conformities identified during inspections Issue non-conformity reports to suppliers and maintain related databases Oversee supplier claims through resolution Support root cause analysis and CAPA implementation with QA, Engineering, and Plant Manager Monitor effectiveness of corrective and preventive actions Regulatory Compliance (Medical Sector) Ensure compliance with applicable quality and regulatory requirements (ISO 13485) Support the creation and update of operating procedures Support internal and external audits (certification bodies, customers)
Ensure proper traceability and documentation of inspection activities Continuous Improvement Identify and promote opportunities to optimize quality controls and manufacturing processes Implement and promote Lean methodologies Support industrialization and production transfer activities, ensuring compliance with quality requirements **Requisiti**:
**Requirements**:
Education Degree in Engineering (Mechanical, Materials, Biomedical) or equivalent technical disciplines Experience At least 5 years of experience in Quality Control within manufacturing environments Experience in the medical device industry is strongly preferred Technical Skills Strong knowledge of: Applied statistics (Cp, Cpk, SPC) Sampling plans (ISO 2859-1, ISO 3951) Excellent ability to read and interpret technical drawings Ability to understand technical standards and international regulations Experience in drafting and reviewing technical documentation Advanced metrology expertise CMM programming skills (ZEISS Contura preferred) Soft Skills Leadership and team management Structured problem-solving approach High attention to detail and accuracy Excellent command of English (both written and spoken) **Altre informazioni**:
**WORK ENVIRONMENT** This job operates in both an office environment and a manufacturing environment. The role routinely uses standard office equipment, such as computers, phones, photocopiers, filing cabinets and fax machines. The individual will be required to adhere to safety policies and procedures on the manufacturing floor. **PHYSICAL DEMAND** Limited physical demand may be needed. Physical demands will involve standing, walking, and occasionally moving or lifting material. **POSITION TYPE/EXPECTED HOURS OF WORK** This is a full-time position, with business core hours
22 ago - Montecosaro
Cronoshare.it
22 ago - San Costanzo
Cronoshare.it
22 ago - Teramo
Cronoshare.it
22 ago - Pergine Valsugana
Cronoshare.it