You must needed to help support a high volume of complaints coming in, The role will be focused on hands-on Complaints Investigation and Medical Device Reporting (MDR), the consultant will need to retrieve the returned device from the facility warehouse and then reverse engineer the product to determine root cause of the complaint. The consultant will need to complete this work in a Complaints Lab (aseptic environment, requires gowning) and also decontaminate the device according to procedures. He or she will be coached on how to investigate the device, but the consultant will also help to develop a system for the team to improve the complaints investigation process.
The Specialist will also be focused on risk management and determining what the threshold is for a product complaint to be reported. The consultant will work through the complaints documentation process to ensure everything is completed accurately and on time.

Top Requirements:

• BS degree minimum
• 3 years of complaints investigation experience with medical device companies
• Strong expertise in Medical Device Reporting
• Strong expertise in risk management and root cause analysis
• An engineering background to take apart the product and determine root cause of the product complaint
• Experience working in a lab setting to investigate and decontaminate product
• Very strong communication skills, adaptable and able to support a broad range of responsibilities

Job Type: Contract

Pay: $56.00 per hour

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Experience:

• medical device companies: 6 years (Required)
• Medical Device Reporting: 6 years (Required)
• risk management and root cause analysis: 6 years (Required)
• lab setting to investigate and decontaminate: 6 years (Required)

Work Location: In person