The Senior Quality Compliance Specialist will support the Critical Care business organization complaint handling unit, and evaluating events for reportability to applicable regulatory bodies.

This position is hybrid (office / remote blend). Selected candidate must reside within reasonable distance to Irvine Corporate Campus location and have ability to commute as required. No relocation available.

Key Responsibilities:

• Assess complaint information provided and conduct additional investigation as needed and escalate as appropriate
• Seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
• Evaluate complaints for Medical Device Reporting (MDR)
• Prepare and submit MDR reports to FDA
• Identify problems and lead projects to improve processes, procedures, and/or practices; recommend and resolve solutions, including devising new approaches to problems encountered
• 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
• Evaluate event to determine if it qualifies as a complaint
• Manage customer relationship and expectations during course of complaint investigation and resolution process
• Prepare and submit final customer correspondence
• Lead and plan agenda for and run 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
• Analyze and/or audit complaint data/files and may develop reports
• Lead the investigation of complaints that include all complex scenarios:
• Other duties assigned by Leadership (Attend cross-functional meetings to represent Quality Compliance and present open items for which resolution is needed)

Education and Experience:
Bachelor's Degree in related field, plus minimum of five (5) years experience in complaint handling or quality compliance required

Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products) or a relative Lifesciences industry required

Additional Skills and Expectations:

• Advanced proficiency in MS Office Suite (Outlook, Word, Excel, etc)
• Demonstrates professional communication skills, interpersonal, and relationship management skills
• Demonstrated problem-solving , critical thinking, and managing competing priorities in a dynamic work environment
• Proficient 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
• Thrives in a collaborative team environment, including inter-departmental teams and key contacts representing the department on projects
• 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 $76,000 to $108,000 (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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