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-bd

Fulfill 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 protec