Sr Quality Compliance Specialist

4 weeks ago


Irvine, United States Hydrogen Group Full time

Job Description:

A leading Medical Device company are actively seeking a motivated candidate to fill their Sr Quality Compliance Specialist role. This is an initial 9-month contract role with opportunity to extend/ convert to FTE. This is an onsite role is based out of Irvine, CA. Salary ranges between $42-47/hour depending on experience.


Requirements:

• Bachelor's Degree or equivalent in related field.

• 5-7 years of Quality Compliance experience required.

• 2+ years’ experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required.

• Hands on experience working with complaint investigations in Medical Device.


Key Responsibilities:

• Manage customer relationships and expectations during the course of complaint investigation and resolution process.

• Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered.

• Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA.


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