Sr Quality Compliance Specialist
3 weeks ago
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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