Quality Compliance Technician

Changing lives. Building Careers.Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.Responsibilities:Manage complaint investigation: communication with intake service, decontamination process, complaint investigation (analysis in laboratory, dimensional analysis, physical-chemical analysis, and any other necessary tests for product investigation and cause identification), review risk files, identify root cause, DHR review, report writing, archiving, escalation to NC or CAPA when applicableImplement and improve procedures related to complaints in accordance with applicable regulations/standards/requirementsTrack Corrective/Preventive/Improvement ActionsParticipate in projects related to complaints activitiesRaise awareness among other departments on complaints processingTrack indicatorsApply procedures related to complaints and material vigilanceQualifications:Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR 2017/745, 21 CFR part 820, Chinese, Canadian, Japanese, Australian, Brazilian regulations, etc.Experience in a Medical Device manufacturing environment is preferred.Training in laboratory techniques in medical fieldsTeamwork abilityAbility to interface with internal and external customersCommunication, organizational, negotiation, and interpersonal skillsRisk management knowledgeRoot cause analysis methodsFluent in English and FrenchProficiency in Microsoft Office tools#J-18808-Ljbffr