Quality Engineer
$75k - $85kClifyX
Quality Engineer
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
Vacancy posted 3 days ago
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