Quality Assurance Engineer - Mechanical

JOB SUMMARY

The Quality Engineer is responsible for coordinating medical device customers’ needs and requirements, as well as handling Major Quality Miscue (MQM) forms.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Work closely with customers to address complaints or concerns
• Handle customer returns and change requests
• Create control plans
• Create, update, and modify PFMEAs
• Troubleshoot and analyze internal failures
• Assist in testing and validation activities
• Create and document Major Quality Miscue (MQM) forms
• Create corrective action reports
• Document and analyze in process failures and rejections (MRB)
• Analyze and report production and test system data
• Perform random inspections
• Create forms, templates, work instructions, or testing procedures
• Coordinate with and assist other departments
• Follow safety rules and keep clean/orderly work area
• Perform other duties as required or assigned

** Job Description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Other duties, responsibilities, and activities may change or be assigned at any time with or without notice. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.**

REPORTING RELATIONSHIP(S):

Reports directly to the Quality Assurance Manager

QUALIFICATION REQUIREMENTS

The requirements listed below are representative of the education, certifications, knowledge, skills, and/or abilities required.

Education / Experience

• BS in engineering or similar areas of study

Knowledge, Skills, and Abilities

• Moderate knowledge of SAP or ERP systems
• Ability to use Microsoft Office to create various documents Basic math skills (standard and metric)
• Ability to follow work instructions accurately
• Ability to do accurate work at a rapid pace
• Ability to communicate clearly and effectively (written and verbal)
• Ability to work well independently as well as with others
• Have attention to detail
• Ability to multi-task
• Ability to proficiently read and write in English
• Ability to follow all safety rules
• Knowledge of KEB products and functions
• Basic understanding of inspection equipment (calipers, micrometers, etc.)
• Ability to read and interpret blueprints, technical data, instruction manuals, test procedures, etc.
• Ability to see and work with small parts with or without accommodation
• Ability to think analytically and problem solve
• Ability to troubleshoot effectively
• Ability to prioritize, balance, and execute several tasks concurrently
• Ability to effectively manage one’s own time
• Ability to exhibit high integrity
• Knowledge of SPC
• Ability to speak on phone for extended periods of time
• Ability to build customer relationships and rapport
• Ability to effectively resolve conflicts and maintain composure in stressful situations
• Ability to effectively manage one’s own time and others

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Majority of time is spent sitting in office environment
• Occasional travel to customer sites

WORKING CONDITIONS

The working conditions described here are representative of those an employee may be exposed to while performing job duties and responsibilities.

• Office environment
• Occasional travel to customer sites