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 FMEAs and providing applicable CAPA statements for complaint related records.
- Monitors and reviews monthly cchart reports and double triggers for complaint trends and provides analysis of the data.
- Generates and champions CAPAs 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 FMEAs 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 centers 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 reusable equipment service and complaint processes.
- Trains on understands and follows company procedures and regulatory requirements.
Basic Qualifications:
- Data analytics and statistical analysis
- Detailoriented.
- Organizational skills.
- Computersavvy skills.
- Technical writing skills.
- Oral and written presentation skills.
- Basic interpersonal skills active listening.
- Software application skills.
- Problemsolving / troubleshooting skills.
- Ability to work in crossfunctional teams
Education and/or Experience:
- Engineering Bachelors 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 Bachelors 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 teamoriented fastpaced environment.
- client is an affirmative action equal opportunity employer that values and actively seeks diversity in the workforce.