Specialist (Regional), Quality Systems (Critical Care)

For over 50 years, the Critical Care business within Edwards has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.If you're eager to contribute your expertise and commitment to Critical Care’s mission, we invite you to explore these career opportunities. Those who join us or continue their current journey within Critical Care will play their own part in improving the quality of care and outcomes for millions of patients around the world.Appendix:On June 3, 2024, Edwards announced that it had entered into a definitive agreement to sell its Critical Care product group to BD (Becton, Dickinson and Company) (NYSE: BDX). It remains business as usual at Edwards until the transaction closes. More information on Edwards’ announcement about the acquisition can be found here: https://www.edwards.com/newsroom/news/2024-06-03-edwards-lifesciences-to-sell-critical-care-to-bdFulfill FDA, ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.How You'll Make An Impact:

Assess complaint information provided; evaluate each event for determination 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)

What You'll Need (Required):

Bachelor's Degree in related field, 3 years experience complaint handling Required and

Medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment Required

What Else We Look For (Preferred):

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 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 California, the base pay range for this position is $65,000 to $92,000 (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 RequirementEdwards 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.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.