Quality Engineer-Medical Devices

PharmEng has immediate opening for a Quality Engineer with experience in medical devices

Essential Job Requirements:

EDUCATION:
Bachelor`s degree in either Biological sciences, chemistry, engineering, computer science and/or regulatory affairs

EXPERIENCE
Need to have experience testing medical devices in preparation for regulatory submission
Minimum of 5-7 years of experience authoring, executing protocols.
Train client employees on protocol execution and deviation management.
Need to be able to collect data and analyze it.
Must be able to design and complete three tests: accelerated, life testing, subsystems testing
MS Office

REQUIRED SKILLS
Validation , equipment Calibration and Change control
Authoring, executing protocols
Design and complete quality tests; including but not limited to accelerated, life testing and subsystems testing
Quality management and techniques
Strong Communication skills both written and oral
Ability to work in cross functional teams

PREFERRED SKILLS
M.SC in related field
ASQ-CQA/CQE, AAMI, AOAC, Six Sigma or IGQA auditor certification
Six sigma Training certification

OTHER REQUIREMENTS
Canadian or USA citizen
Valid Driving license and Passport
Ability to Travel
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Only those candidates selected will be contacted for an interview.

• Compensation: TBS
• Principals only. Recruiters, please don`t contact this job poster.
• Please, no phone calls about this job!