Job description

Provide clinical expert knowledge and clinical guidance to Quality Engineering and other cross functional teams to understand the nature of complaints and possible health risks.

Key Responsibilities:

• Provide medical/clinical guidance to complaint staff and engineers related to event interpretation, event investigation, proper coding, required regulatory reporting (MDR, MDV, etc.), and complaint closure. Author and/or review complaint conclusions/closure statements and customer letters. And may assist with and help manage Imaging Reviews
• Educate complaint staff and engineers to understand the medical aspects of complaint information and associated procedures including health risks and may develop clinically based training materials. May provide training to complaint staff on patient anatomy and medical conditions, products and procedure, and internal policies and procedures. Provide complaint training to Sales, Marketing and other customer facing staff.
• Perform complaint trending analyses, participate in quality metrics review meetings, and communicate complaint data and relevant clinical information to internal customers in quality, manufacturing and new product development
• 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
• Work with VP Product Safety and/or Director of Quality to maintain Decision Rationale Matrix to guide complaint staff in reporting decisions. Review/assist with reporting decisions.
• 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.
• May participate in review of/provide clinical guidance for new product development risk management documentation (e.g., FMEAs)
• May provide clinical input to Product Risk Assessments (PRA), and participate in Risk Management Councils and Quality Boards.
• Other incidental duties: May participate in internal and external audits as Complaint SME

Education and Experience:
Bachelor's Degree in in related field , 8 years years experience of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (i.e. cardiac care, ICU, OR, or cardiovascular/endovascular interventions) Required
Other: Experience working in a large manufacturing company Preferred

Additional Skills:

• Proven successful project management skills
• Strong presentation and public speaking skills
• Proven expertise in both Microsoft Office Suite, including advanced Excel and QMS (Quality Management System)
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive understanding of FDA’s Quality System Regulation
• Working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD 93/42/EEC and other applicable regulatory requirements.
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Represents leadership on sections of projects within a specific area interfacing with project managers and quality compliance team
• Consult in project setting within specific sections of quality compliance area
• Provides quality compliance leadership to outsourcing partners on a task level
• 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 Washington, the base pay range for this position is $111,000 to $158,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

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 13,000 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.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice

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