Senior Quality Compliance Specialist

Position Overview:

Evaluate global complaint information provided, conduct additional investigation as needed and escalate as appropriate. Evaluate complaints for Medical Device Reporting (MDR). Prepare and submit MDR reports to FDA. Process complaint files from initiation to closure.  Fullfill FDA, ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.

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)
• While this role can be remote, the core work hours will need to be either 7am - 4pm PST; or 8am - 5pm PST

Required / Minimum Qualifications:

• Bachelor's Degree plus 5 years of experience with complaint handling related responsibilities; OR Master's Degree with 3 years of experience with complaint handling related responsibilities.
• Medical Device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment.

Preferred Qualifications:

• Experience submitting Medical Device Reports
• Strong knowledge and familiarity with 21 CFR 820 & 803 regulations
• Proven expertise in MS Office Suite and ability to operate general office machinery
• Experience working in a medical device industry
• Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
• Demonstrated problem-solving, critical thinking, and investigative skills working relationships
• Substantial knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
• Proficient knowledge of medical terms and human anatomy
• Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
• Ability to manage confidential information with discretion

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.

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., geographic location, qualifications, education, prior experience).   

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

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