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QA Inspector (DHR review)

QA Inspector (DHR review)

Edwards LifesciencesNaperville, IL, US
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Implantable Heart Failure Management Team Member

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact :

As a member of the Quality team, you will perform final review and release of Device History Records (DHRs). Key responsibilities include :

  • Verify DHR is ready for release and perform releases in ERP system (i.e. JDE)
  • Receive, review, and log Device History Records (DHR) with increasing complexity (e.g., rework DHRs)
  • Generate reporting to indicate status of releases
  • Work with Warehouse to resolve quantity discrepancies
  • Review NCR status and disposition prior to work order release
  • Collaborate with engineers to resolve moderately complex DHR issues
  • Assist management with pre-release closures per procedure
  • Serve as a back-up for team members
  • Initiate NCRs in QMS system and aid in investigation if needed; Provide training and coaching to lower level employees

What you'll need (Required) :

  • H.S. Diploma or equivalent
  • 2 years previous related experience Required
  • What else we look for (Preferred) :

  • Good computer skills including Microsoft Office Suite, Adobe, JDE, Ignite portal, and QMS (Quality Management System)
  • Good communication and interpersonal relationship skills
  • Good critical thinking and problem solving skills
  • Able to read, write, comprehend, and speak English
  • General knowledge and understanding of Edwards policies and procedures
  • Good problem-solving skills
  • Attention to detail
  • Ability to continuously focus on reviewing detailed paperwork
  • Ability to interact with contacts across the organization
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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 / control
  • Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

    For Illinois, the base pay range for this position is $42,000 to $57,000 (highly experienced).

    The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

    Edwards is an Equal Opportunity / Affirmative Action employer including protected Veterans and individuals with disabilities.

    COVID Vaccination Requirement

    Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

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    Qa Inspector • Naperville, IL, US

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