Edwards Lifesciences
Global leader in the medical device industry with a patient-focused culture of innovation
Product Quality Manager
Location
Arizona + 4 moreAll locations: Arizona, California, Nevada, Oregon, Utah
Posted
45 days ago
Salary
$126K - $178K / year
Seniority
Lead
Bachelor Degree8 yrs expEnglish
Job Description
• Provide medical/clinical guidance to complaint staff and engineers related to event interpretation, event investigation, proper coding, and required regulatory reporting (MDR, MDV, etc.)
• Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution.
• May provide training to complaint staff on patient anatomy and medical conditions, products and procedure, and internal policies and procedures.
• Perform complaint trending analyses, participate in quality metrics review meetings.
• May analyze and interpret aggregate complaint data for a specific product line, business unit, regulatory submissions, regulatory agency requests, and/or management report including ad hoc report summaries.
• Communicate complaint data and relevant clinical information to internal customers in quality, manufacturing and new product development in support of complaint investigations
• Support process improvement projects as needed.
Job Requirements
- Bachelor's Degree or equivalent in a related field or equivalent work experience based on Edwards criteria
- Eight years of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (e.g. cardiac care RN, Practitioner, Physician, ICU, OR, or cardiovascular/endovascular interventions)
Benefits
- Competitive salaries
- Performance-based incentives
- A wide variety of benefits programs to address diverse individual needs
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