ALOIS LLC
Location
Sparks, NV | United States
Job description
Description:
Work days/hours: M - F 8am - 5pm
ONSITE DAILY
***Minimal travel to New Hampshire - 5-10% of the time at most (will fly)***
Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and or maintenance of products or services. The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.
Demonstrates intermediate knowledge of quality engineering policies, principles and best practices
Demonstrates intermediate knowledge of FDA/ISO requirementsApplies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity
May act as mentor to less experienced team membersApplies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision
Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intendedHas in-depth experience, knowledge and skills in own job family
Applies knowledge and skills to a wide range of standard and non-standard situations
Works independently with minimal guidance
Usually determines own work priorities Acts as a resource for colleagues with less experience
Education requirements:
Bachelor's degree with 5 years of experience in a regulated environment or MS with 3 years of experience. Typical degree in Electrical or Mechanical or Industrial Engineering.
Experience:
Medical Device experience preferred
Preferred: Certification such as ASQ-CQA/CQE, AAMI, Six Sigma or a Company certification such as Green Belt, Black Belt, IGQA auditor.
Job tags
Salary
