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Assoc Quality Compliance Specialist

Company: TalentBurst, Inc.
Location: Irvine
Posted on: November 24, 2022

Job Description:

Job Title: Assoc Quality Compliance Specialist
Irvine, CA
08+ Months

Duties: -Assist with senior team members with complaint investigations Investigate routine complaints -Evaluate event to determine if it qualifies as a complaint -Manage customer relationship and expectations during course of complaint investigation and resolution process -Assist with assessment of complaint information provided and conduct additional investigation as directed and escalate as appropriate -May evaluate complaints for Medical Device Reporting (MDR) -May prepare and submit MDR reports to FDA -Summarize routine findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions -May prepare and submit final customer correspondence


Skills: Additional Skills: " Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required " Proven expertise in MS Office Suite and ability to operate general office machinery " Excellent written and verbal communication skills and interpersonal relationship skills " Demonstrated problem-solving , critical thinking, and investigative skills " Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance " Good knowledge of medical terms and human anatomy " Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations " Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing " Ability to manage confidential information with discretion " Attention to detail " Ability to interact professionally with all organizational levels " Ability to manage competing priorities in a fast paced environment " Work is performed independently on complex work and reviewed for accuracy and soundness
Keywords:
Education: Education and Experience: Bachelor's Degree or equivalent in related field (Med Device, Quality Assurance, Regulatory Compliance), 2 years experience quality compliance preferred.

Keywords: TalentBurst, Inc., Irvine , Assoc Quality Compliance Specialist, Other , Irvine, California

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