Field Assurance/ Quality Assurance

Position : Field Assurance/ Quality Assurance

Location : Tempe, AZ

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client : Medical Devices Company

Job Category : Professional

Level of Experience : Entry Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Job Description:

• This Technician for Field Assurance (FA) role involves overseeing daily operations in the Field Assurance (Complaint Handling) Lab.
• Responsibilities include managing the shipping, receiving of complaint samples, and conducting image reviews associated with complaints promptly.
• Familiarity with biosafety and good laboratory practices, as well as experience working in a clean room environment, is preferred.

Responsibilities :

• Documentation of complaint samples received in the Field Assurance Lab for evaluation purposes
• Support daily requests for sample return kits to be shipped domestically and internationally, maintain tracking documentation, communicate in a timely manner with the requestor, assembly sample return kits and warehouse pickup and drop-offs
• Ensure accurate and timely shipping of sample return kits
• Track shipping inventory and order supplies through approved vendors
• Oversee image/video review requests received as a task, run a query in TrackWise to capture all requests and process requests in a timely manner. Additionally, maintain the image/video review tracker and follow up on any pending requests.
• Maintain good documentation practices (GDP) when recording preliminary and sample analysis results
• Escalate all unexpected issues to the Supervisor/Manager
• Maintain good laboratory practices (GLP) consistent with biosafety laboratory practices
• Maintains a clean work environment
• Maintains a professional working relationship with internal and external customers and support staff
• Storage and disposal of complaint samples in accordance with applicable procedures
• Support continuous improvement of lab processes
• Understand and follow procedures and regulatory requirements

Required Qualifications:

• Good written and verbal communication skills
• Detail-oriented
• Ability to work independently and in cross-functional teams
• Basic problem-solving / troubleshooting skills
• Must have proof of Hep B series, be willing to undergo Hep B series, or sign waiver
• Proficient in MS Office
• Requires the ability to lift at least, but no limited to 50 lbs.

Preferred Qualifications :

• Knowledge of the FedEx shipping system to conduct precise shipping transactions
• Previous warehouse experience
• Medical industry (GMP) and/or lab experience preferred

Education and/or Experience:

• High school diploma, GED, or equivalent
• Associated degree or equivalent experience

Physical Demands:

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