Quality Engineer

Quality Engineer

Department - Post Marketing Safety Surveillance

Role: Quality Engineer

Duration of the requirement: 24 months

Number of position: 1

Project Start Date: 19th Mar 2018

Compensation: Between: 75-85K USD per year

Please do not submit any resumes above $85k

Must Have Skills

• A 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 industry
• Experience in complaint handling, DFMEA, MDR & strong knowledge in Microsoft excel.
• Strong Presentation skill
• Excellent Interpersonal skills that foster conflict resolution as it relates to technical situations
• Ability to collaborate with business partners at all levels across multiple functional groups
• Knowledge of process and design excellence tools

Good to Have Skills

• Minitab experience is preferred
• Six Sigma Green or Black Belt preferred
• Prior experience leading teams and/or projects

Key Responsibilities

• Perform post-market safety and surveillance activities
• Systematic collection, analysis and evaluation of product safety and performance data
• Conduct trend analysis, signal detection and product investigations with the focus on early warning of patient safety & product quality issues
• Get complete understanding of the current risk profile of our products while assessing the overall risk/benefit of the product
• Review and update risk management files for completeness and accuracy
• Lead & support corrective and preventative actions to address product issues and facilitate field actions
• Support quality system activities - Complaint Investigations, Internal Audits, and third party inspections
• Interface with key business partners all levels across multiple functional groups including R&D, Operations, Medical and Marketing, Quality & Regulatory Compliance group