Quality Engineer (169-178) Salient Surgical Technologies, Inc.

Tracking Code
169-178
Job Description

Interfaces with quality, R& D, operations and contract manufacturers to assure that design controls, manufacturing controls and other quality system requirements are met. Performs statistical analysis and tests.

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.

Required Skills

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 compile status reports.
Externally Focused, Committed, Clearly Communicates, Team Player, Innovative, Able to Execute

Required Experience

Bachelors degree in Mechanical or Electrical Engineering
Two years medical device industry experience preferred but not mandatory.
Position Type
Full-Time/Regular.

Location:	Portsmouth, NH United States