Edwards Lifesciences logo
Edwards Lifesciences

Global leader in the medical device industry with a patient-focused culture of innovation

Product Quality Manager

ManagerManagerFull TimeRemoteLeadTeam 10,001+Since 1958H1B SponsorCompany SiteLinkedIn

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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