04 ago - Mirandola
Experteer Italy
ppAs a Quality Engineer, you will support product development, process validation, and quality improvements in a highly regulated medical device setting. You’ll collaborate with RD, Manufacturing, and Quality to ensure compliance with ISO 13485, GMP, and other standards while driving safer, more reliable devices. Your work will influence design control, validation activities, and defect investigations, shaping product quality across the lifecycle. This role offers meaningful impact on patient safety and a culture of continuous improvement in a global team. /pulliFlexible working options /liliMedical insurance /liliEmployee stock purchase plan /liliGlobal recognition programme /liliAdditional location-based benefits /liliPartner with RD and Engineering to define product and process requirements /liliSupport Design Control throughout the product development lifecycle /liliReview verification/validation plans, protocols,
and reports /liliReview process validation activities for compliance /liliLead change impact assessments and quality implications of changes /liliCoordinate investigations for verification/validation failures /liliEstablish and maintain product quality control plans /liliLead quality improvement initiatives in manufacturing operations /liliAnalyze nonconforming products and support disposition decisions /liliLead root cause investigations for production or customer-related failures /liliManage CAPA activities and analyze quality trends /liliSupport suppliers and external manufacturers with quality issues /liliContribute to risk assessments and Health Hazard Assessments when required /liliDegree in Engineering, Chemistry, Biology, Physics, or another scientific discipline (educational background acceptable) /lili1–3 years of experience in Quality Assurance in Medical Device or Pharmaceutical industry /liliExperience supporting product design and development activities /liliStrong understanding of Product Development Processes and Design Control principles /liliKnowledge of ISO 13485 and Quality Management Systems /liliUnderstanding of GMP /liliExperience with validation activities, CAPA management, nonconformance investigations, and root cause analysis (strong advantage) /liliStrong analytical and problem-solving skills /liliAbility to work in cross-functional teams /liliGood communication and stakeholder management skills /li /ul /p #J-18808-Ljbffr
06 ago - Sommacampagna
PENTA FORMAZIONE
06 ago - Bresso
ETJCA
06 ago - Creazzo
Ali S. P. A
06 ago - Vicenza
Adecco Italia