Quality Compliance Associate II - Cardiac Surgery Systems
Location: Salt Lake City Utah
Description: Edwards Lifesciences is employing Quality Compliance Associate II - Cardiac Surgery Systems right now, this occupation will be placed in Utah. Further informations about this occupation opportunity please read the description below. Quality Compliance Associate II to Fulfill FDA, ISO and other relevant requirements for designated complaint handling unit, and ! evaluation of events for reportability to applicable regulatory bodies.
Responsibilities:
Investigate complaints that include a variety of complex scenarios:
Evaluate event to determine if it qualifies as a complaint
Manage customer relationship and expectations during course of complaint investigation and resolution process
Assess complaint information provided and conduct additional investigation as needed and escalate as appropriate
Seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
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 corr! espondence Plan agenda for and run 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
Identify problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered
Analyze complaint data and develop reports
Other incidental duties (Attend cross-functional meetings to represent Quality Compliance and present open items for which resolution is needed, plan and implement
A Bachelor’s degree is required. A minimum of 3 -5 years work experience within the medical device (cardiovascular, endovascular, or other critical care/surgical products a plus), healthcare, or a related industry, including complaint handling experience is required.
Required Skills:
Knowledge and understanding of medical terms, Medical Device Reporting regulatio! ns, regulatory reporting regulations, GMPs for medical devices and human anatomy preferred
Excellent written, oral and listening communication skills in order to interact with customers and other professionals and generate clear, concise responses
Proficiency in the use of personal computers required (i.e., Microsoft Office applications.)
Ability to:
Navigate through complex software systems
Interact with individual and groups at all levels
Identify priorities and function independently required Demonstrate investigative and analytical skills
Demonstrate good presentation/training skills
Additional Information: Travel Percentage: 10%
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If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Edwards Lifesciences.
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This occupation starts available on: Thu, 24 Oct 2013 21:59:18 GMT
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