Post Market Surveillence I Complaints - Medical Device #7323

About the role

This role will be responsible for documenting and closing out customer complaints regarding medical device performance, ensuring compliance with FDA 21 CFR 820, ISO 13485, and MDR regulations. Key duties involve interacting with customers and collaborating with engineering/quality teams.

What You’ll Do

• Process complaints to ensure that complaints are documented, reviewed, and formally closed in a timely manner.
• Responsible for evaluating and processing complaints received by a client.
• Support complaint receiving and handling (documentation, coordination, resolution, and closeout).
• Support with follow-up activities (e.g., additional information and product).
• Support complaint closure within Complaint Management System (CMS).
• Regularly report to various levels of ECI/client management on the progress of Complaints.
• Interface directly with client’s internal and external customers and regulatory agencies as required.
• Perform additional tasks as mutually agreed upon by the client and ECI, provided they are reasonable and do not require project scope re-evaluation.

What We Look For

• Bachelor’s degree in engineering, biomedical engineering, or scientific field, or equivalent industry experience.
• 2-4 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device industry.
• Knowledge of FDA 21 CFR Part 820, 21 CFR Part 803 (MDR), and ISO 13485.
• Experience with QMS software and databases, plus the ability to read technical documents.
• Professional verbal and written communication skills to interact with clinicians and users.
• Excellent documentation skills for creating detailed investigation reports.
• Strong ability to analyze complex data to identify patterns.

Benefits

ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from now or in the future.