Quality Engineer I

Job Description

Job Summary:

• The Quality Test Engineer performs investigations relating to root cause of customer complaints, proposes and implements corrective and preventative actions as required.

Duties & Responsibilities:

• Under supervision, general direction, and in accordance with all applicable federal, state and local laws/regulations and Corporate Client, procedures and guidelines, this position is Responsible for investigating customer complaints regarding product design, product manufacture, and product testing.
• Responsible for communicating quality and business-related issues or opportunities to the next management level.
• Participates in projects that improve the complaint process and reduces overall customer issues.
• Actively participate and engage in CAPA trending meetings.
• Analyzes data and applies knowledge of engineering principles and practices to implement continuous improvement projects.
• Provide support during External and Internal Audits of the Customer Quality process.
• Performs other duties assigned as needed.
• Responsible for complying with all Federal, State, local and company regulations, policies and procedures including Health, Safety and Environmental compliance.

Required Qualifications:

• Bachelor’s degree in engineering.
• Minimum of two (2) years of experience in an engineering related field.
• Able to read and understand electrical and mechanical schematics.
• Strong integration skills to identify Manufacturing and Supplier related issues of Medical Device Capital Equipment.
• Ability to apply technical, regulatory, quality systems, and business knowledge to identify, investigate and resolve customer complaints.
• Ability to effectively prioritize and manage multiple activities and responsibilities.
• Has an understanding of statistics and how to utilize them in data analysis
• Must possess a clear understanding of theoretical and practical fundamentals and experimental engineering techniques.
• Good written and oral communication skills. Computer literate.
• Demonstrated root cause and problem-solving skills.
• Demonstrated verbal and written communication skills, and ability to effectively communicate with internal and external personnel.
• Ability to apply Six Sigma and Process Excellence tools and methodologies preferred.
• Understanding of Failure Modes and Effects Analysis and Fault Tree Analysis are preferred.
• Understanding of Human Factors and Health Hazard Risks are preferred.
• Knowledge of design control, risk management, production and process controls and applicable laws (i.e., ISO 13485, FDA Quality System Regulation, ISO 14971) is preferred.
• Proficiency with quality-related applications such as those for Minitab, QI Macros, etc would be a plus.
• Experience with CAPA, Client and Audit software systems is desired.