Quality Engineer

ppDescrizione dell’offerta di lavoro /p pAs a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you’re looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives. /p h3Who are we looking for: /h3 pAre you passionate about quality, product development, and ensuring that healthcare products meet the highest standards of safety and compliance? We are looking for a Quality Engineer to join our Quality team and play a key role in supporting product development, process validation, and quality improvement activities within a highly regulated medical device environment. /p pIn this role, you will work closely with RD, Manufacturing, and Quality teams, contributing to the development and maintenance of innovative medical devices while ensuring compliance with international quality and regulatory standards. /p pThis opportunity is ideal for someone with experience in Product Development, Design Control, and Quality Assurance, who enjoys solving complex quality challenges and collaborating across functions to drive continuous improvement. /p h3Your new role: /h3 ul liPartner with RD and Engineering teams to define product and process requirements. /li liSupport Design Control activities throughout the product development lifecycle. /li liReview product verification and validation plans, protocols, and reports. /li liReview process validation activities to ensure compliance with quality requirements. /li liParticipate in change impact assessments and evaluate quality implications of product or process changes. /li liCoordinate investigations related to verification and validation failures. /li liEstablish and maintain product quality control plans. /li liIdentify and lead quality improvement initiatives within manufacturing operations. /li liAnalyze nonconforming products and support disposition decisions. /li liLead root cause investigations for product and component failures identified during production or through customer complaints. /li liManage CAPA activities and analyze quality trends to identify improvement opportunities. /li liSupport suppliers and external manufacturing partners in addressing quality issues and nonconformities. /li liContribute to risk assessments and product safety evaluations, including Health Hazard Assessments (HHA) when required. /li /ul h3How you'll make an impact: /h3 ul liEnsure that medical devices are developed and manufactured in compliance with regulatory and quality requirements. /li liAct as the Quality representative within cross-functional product development projects. /li liSupport the successful launch and maintenance of products by identifying risks and quality concerns early in the process. /li liImprove manufacturing quality performance through structured problem solving and continuous improvement initiatives. /li liDrive investigations and corrective actions that enhance product reliability and patient safety. /li liContribute to maintaining a strong Quality Culture across the organization. /li /ul h3About you: /h3 ul liDegree in Engineering, Chemistry, Biology, Physics, or another scientific discipline. /li li1-3 years of experience within Quality Assurance in the Medical Device or Pharmaceutical industry. /li liExperience supporting product design and development activities. /li liGood understanding of Product Development Processes and Design Control principles. /li liKnowledge of ISO 13485 and Quality Management Systems. /li liUnderstanding of Good Manufacturing Practices (GMP). /li liExperience with validation activities, CAPA management, nonconformance investigations, and root cause analysis is considered a strong advantage. /li liStrong analytical and problem-solving skills. /li liAbility to work effectively in cross-functional teams. /li liGood communication and stakeholder management skills. /li liFluent English, both written and spoken. /li liProficient in Microsoft Office Suite. /li /ul h3What you will find: /h3 ul liThe opportunity to work on products that directly impact patients’ lives. /li liExposure to the full product development lifecycle within the medical device industry. /li liA collaborative environment where Quality, RD, and Manufacturing work closely together. /li liThe chance to develop expertise in Design Quality, Validation, Risk Management, CAPA, and Product Development Processes. /li liContinuous learning opportunities within a highly regulated and innovation-driven industry. /li liA dynamic and international environment focused on quality, compliance, and continuous improvement. /li liCareer growth opportunities within Quality Engineering and Product Development functions. /li liLocation: Mirandola, Italy /li /ul h3WHAT WE CAN OFFER YOU: /h3 ul liNational Collective Bargaining Agreement: CCNL Gomma Plastica /li liLevel: A/C /li liBase Salary range: Visualizzare il telefono su click.jobroute.io /li liBonus: 0-5% /li liActual compensation will be determined based on relevant experience, qualifications, and internal equity considerations. /li liWe offer a competitive benefits package including: /li liFlexible working options. /li liMedical insurance. /li liPension scheme. /li liEmployee stock purchase plan. /li liGlobal recognition programme. /li liAdditional benefits (e.g. meal vouchers, flexible benefits, local bonuses) may apply depending on location. /li liIn addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with a competitive package, including financial and wellbeing benefits. /li /ul h3Summary /h3 pLocation: Mirandola, Italy /p pType: Full time /p /p #J-18808-Ljbffr