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.

Responsabilities

•    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 applicable
•    Implement and improve procedures related to complaints in accordance with applicable regulations/standards/requirements 
•    Track Corrective/Preventive/Improvement Actions
•    Participate to projects related to complaints activities
•    Raise awareness among other departments on complaints processing
•    Track indicators
•    Apply procedures related to complaints and material vigilance.

Qualifications

•    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 technics in medical 
•    Teamwork ability
•    Ability to interface with internal and external customers
•    Communication, organizational, negotiation and interpersonal skills 
•    Risk management knowledge
•    Root cause analysis methods
•    Fluent in English and French
•    Use of Microsoft office tools