Specialist, Quality Compliance
Required skills
- complaint handling
- Medical Device Reporting
- MDR
- FDA
- process improvement
- investigative skills
- Edwards policies
- quality compliance
Nice to have
- MS Office Suite
- medical device
- cardiovascular
- endovascular
- critical care
- surgical products
Role summary
This role supports quality compliance activities within the Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit, focusing on groundbreaking medical technologies for heart valve disease. The Specialist will assess complaint information, manage customer relationships during investigations, and collaborate with departments like Product Safety and Engineering. Key responsibilities include evaluating complaints for Medical Device Reporting (MDR) to the FDA, summarizing findings, and preparing final customer correspondence. The role also involves identifying and leading process improvement projects. A minimum of 3 years of experience in complaint handling is required, with preferred experience in the medical device industry and knowledge of MDR regulations and GDP.
Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. In this role, you will apply professional expertise and judgment to support quality compliance activities and business outcomes.
How you will 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
- Other duties assigned by Leadership (May assist in auditing complaint files)
What you'll need (Required):
- 3 years’ experience complaint handling or equivalent work experience based on Edwards criteria
What else we look for (Preferred):
- Proven expertise in MS Office Suite and ability to operate general office machinery
- Medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment or equivalent work experience based on Edwards criteria preferred.
- 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Originally posted on Himalayas
Similar roles
- Principal Supplier Quality Engineer, Contract Manufacturing (CMO)Edwards Lifesciences · Remote · Remote
- Senior Engineer, New Product IntroductionEdwards Lifesciences · Usa Irv-17011 Redhill/dbc1-5, CA · Onsite
- Bilingual Customer Relations SpecialistSunsolar Solutions · Peoria, AZ · Onsite
- SpecialistNorrell Construction Management · Deer Park, TX · Onsite
Store Customer Service Specialist - Part Time (El Cajon)Sherwin-Williams · El Cajon, CA · Onsite- Funeral Home Transfer Care SpecialistFoundation Partners Group · Colorado Springs, CO · Onsite
