ESSENTIAL DUTIES AND RESPONSIBILITIES -
Conducts evaluations and statistical tests to solve complex problems involving component and system interdependences. Provides statistical sampling size determinations.
Conducts parametric and/or destructive physical analyses of failed parts in order to determine the root cause. Implements appropriate corrective actions.
Assists in product risk management activities such as FMEAs and FTAs.
Assists in verification and validation activities.
Maps processes and assists in improving efficiency and quality.
Conducts internal and supplier audits and writes audit reports.
Streamlines data collection and analysis. Automates data collection processes.
Conducts vendor audits as required and writes audit reports.
DESIRED MINIMUM QUALIFICATIONS
Education and experience:
Bachelors degree in Mechanical or Electrical Engineering
Two years medical device industry experience preferred but not mandatory.
Necessary knowledge, skills and abilities:
Knowledge of medical device quality systems principles, practices, and methods.
Knowledge of statistics for quality data analysis
Certified Quality Engineer (CQE) certification preferred.
Skill in operating the listed tools and equipment.
Ability to communicate effectively, orally and in writing, with employees and governmental agency representatives. Ability to compile status reports.

Please email resumes to edoyon@keypartnersinc.com.