Position       : Capital Systems & Services Quality Engineer

Location : Tempe, AZ

Duration : 6 Months Contract

Total Hours/week : 40.00

1st shift

Description:

Overview:

• This position is an entry level engineering position within the Capital Systems & Services department.
• The engineer will be responsible for providing engineering and technical support to the Capital Systems & Services department regarding client equipment service, repair, and complaint processes.
• (Per applicable standards, operating procedures, and work instructions.)

Summary of Position with General Responsibilities:

• Actively supports the Capital Systems & Services Department by reviewing unexpected events, reviewing related FMEA’s, and providing applicable CAPA statements for complaint related records.
• Monitors and reviews monthly c-chart reports and double triggers for complaint trends and provides analysis of the data.
• Generates and champions CAPA’s as needed to drive change, determine root cause, and resolution.
• Handles the majority of Complaint Investigation write ups and Quality reviews for all equipment related complaints following service center evaluation and repair.

Essential Job Functions:

• Perform data analysis to determine trends using advanced statistical techniques.
• Review & analyze data trends related to out of box failures and unexpected event details for all client equipment.
• Review and update FMEA’s as needed.
• Review and update complaint failure coding as needed for trending analysis.
• Review and investigate double trigger complaint events
• Generate corrective and preventative action plans within the CAPA system.
• Perform and support root cause analysis of reusable BDPI equipment.
• Write complaint investigations based on the service center’s investigation, repair, and root cause analysis.
• Perform quality reviews following the complaint investigation write up. (QA process step.)
• Provide technical support for service related questions and equipment functionality for CS&S department.
• Assist in the reviewing and updating of CS&S documentation related to re-usable equipment service and complaint processes.
• Trains on, understands, and follows company procedures and regulatory requirements.

Basic Qualifications:

• Data analytics and statistical analysis
• Detail-oriented.
• Organizational skills.
• Computer-savvy skills.
• Technical writing skills.
• Oral and written presentation skills.
• Basic interpersonal skills – active listening.
• Software application skills.
• Problem-solving / troubleshooting skills.
• Ability to work in cross-functional teams

Education and/or Experience:

• Engineering Bachelor’s degree
• 2 years preferred experience
• Excellent written and oral communication skills
• Medical industry (GMP) experience preferred
• Proficient in MS Office (Excel preferred)

Minimum Educational Requirements:

• Engineering Bachelor’s degree

Physical Demands:

• While performing the duties of this job, the employee is regularly required to stand, walk, sit, and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

• While performing the duties of this job, the employee may be in an open cubicle environment.
• Candidate must be able to work in a team-oriented, fast-paced environment.
• client is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.