Quality Compliance Engineer - Irvine, CA - Hiring Immediately

Summary:
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
5-7 years of experience required