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Quality Compliance Specialist

2 months ago

Irvine, United States Compunnel Inc. Full time

Job Description: The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate


Key Responsibilities:

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

• Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations.

• 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.

• Summarize 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.

• Prepare and submit final customer correspondence.

• Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint.


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


Education and Experience:

• Bachelor's Degree or equivalent in related field

• 0-2 years of experience required