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Edwards Lifesciences: Specialist, Quality Compliance (Critical Care)

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

Job Description:

Edwards' innovative Critical Care organization is seeking a Quality Compliance Specialist to fulfill FDA, ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.Key Responsibilities: Assess complaint information provided; evaluate each event fordetermination if it qualifies as a complaint; escalate as appropriate 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 Other duties assigned by Leadership (May assist in auditing complaint files)Education and Experience:Bachelor's Degree in relevant field and 3 years of complaint handling experience is required in the medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related industryAdditional Talents and General Expectations: Proven expertise in MS Office Suite and ability to operate general office machinery Excellent written and verbal communication skills and interpersonal relationship skills Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required Demonstrated problem-solving, critical thinking, and investigative skills Ability to build stable working internal/external relationships 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 Must be able to work in a team environment, including inter-departmental teams and representing the department on specific projects Ability to build productive internal/external working relationships Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences, Irvine , Edwards Lifesciences: Specialist, Quality Compliance (Critical Care), Other , Irvine, California

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