Quality Engineer

Quality EngineerRole: Quality EngineerDuration of the requirement: 24 monthsNumber of position: 1Project Start Date: 19th Mar 2018Compensation: Between: 75-85K USD per yearPlease do not submit any resumes above $85kMust Have SkillsA Bachelor's Degree in an Engineering or Scientific discipline. An Advanced Degree in a related field is an asset.A minimum of 4-5 years' experience in Post Marketing Surveillance for highly regulated industry.A minimum of 2 years in Medical Device / Diagnostic / Pharmaceutical industryExperience in complaint handling, DFMEA, MDR & strong knowledge in Microsoft excel.Strong Presentation skillExcellent Interpersonal skills that foster conflict resolution as it relates to technical situationsAbility to collaborate with business partners at all levels across multiple functional groupsKnowledge of process and design excellence toolsGood To Have SkillsMinitab experience is preferredSix Sigma Green or Black Belt preferredPrior experience leading teams and/or projectsKey ResponsibilitiesPerform post-market safety and surveillance activitiesSystematic collection, analysis and evaluation of product safety and performance dataConduct trend analysis, signal detection and product investigations with the focus on early warning of patient safety & product quality issuesGet complete understanding of the current risk profile of our products while assessing the overall risk/benefit of the productReview and update risk management files for completeness and accuracyLead & support corrective and preventative actions to address product issues and facilitate field actionsSupport quality system activities - Complaint Investigations, Internal Audits, and third party inspectionsInterface with key business partners all levels across multiple functional groups including R&D, Operations, Medical and Marketing, Quality & Regulatory Compliance group