Senior Quality Compliance Specialist, MDR / Vigilance Reporting & Complaint Handling
Full-time
8 months ago
Employment Information
**This position can be fully remote, as long as the successful candidate is residing within the United States.
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.
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.
Fulfill FDA, ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.
How you will make an impact:
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)
What you'll need (Required):
Bachelor's Degree
Five (5) years of experience with complaint handling and evaluating complaints for MDR (Medical Device Reporting).
Medical Device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment/industry experience.
What else we look for (Preferred):
Experience submitting Medical Device Reports
Proficient knowledge of medical terms and human anatomy
Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
Strong knowledge and familiarity with 21 CFR 820 & 803 regulations
Proven expertise in MS Office Suite and ability to operate general office machinery
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
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.
For California, the base pay range for this position is $78,000 to $110,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.
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.
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.
Fulfill FDA, ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.
How you will make an impact:
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)
What you'll need (Required):
Bachelor's Degree
Five (5) years of experience with complaint handling and evaluating complaints for MDR (Medical Device Reporting).
Medical Device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment/industry experience.
What else we look for (Preferred):
Experience submitting Medical Device Reports
Proficient knowledge of medical terms and human anatomy
Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
Strong knowledge and familiarity with 21 CFR 820 & 803 regulations
Proven expertise in MS Office Suite and ability to operate general office machinery
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
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.
For California, the base pay range for this position is $78,000 to $110,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.
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