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.
How you will make an Impact:
We are seeking a qualified Complaint Handling Specialist to support global Complaint Handling and vigilance activities. This role is responsible for ensuring compliance with applicable medical device regulations, ISO standards, and internal quality requirements worldwide (excluding the US and Japan).
Investigate complaints that include moderately complex scenarios:
Evaluate event to determine if it qualifies as a complaint
Manage customer relationship and expectations during course of complaint investigation and resolution process
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 to competent authorities
Prepare and submit reports to Competent Authorities, after review by more senior team member after review by more senior team member
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, after review by more senior team member
May plan agenda for and run 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.
May lead projects to improve processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered.
What you will need (Required):
Bachelor's Degree in related field.
Experience in the medical device industry (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related regulated environment.
Prior experience in complaint handling, vigilance, or a quality-related role.
Knowledge of medical device regulations and/or ISO 13485 / ISO 9001 standards.
Advanced English proficiency (written, spoken, and listening).
What else we look for (Preferred):
Demonstrated leadership capabilities.
Strong problem-solving and critical thinking abilities.
Proactive mindset with a high level of accountability.
Ability to work independently and in teams.
High attention to detail and strong organizational skills.
Ability to manage multiple priorities in a fast-paced environment.
Excellent written and verbal communication skills.
Proven ability to build professional working relationships across all organizational levels.
Proficiency in Microsoft Office Suite and general office systems.
Good understanding of medical terminology and human anatomy.
Solid knowledge of Good Documentation Practices (GDPs).