Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevents future issue
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What You Will Do
Morning Report Instruction for specific work items needed.
Basic understanding of how to comply with constantly changing regulatory procedures preferred.
Develop basic knowledge and understanding of complaint handling process as required by regulatory agencies.
Support to the Post-Market Quality team that is responsible for both domestic and international complaint handling.
Specifically, this position is responsible for the coordination of material and information to meet quality and regulatory requirements.
Monitor and facilitate product return for complaint investigation and analysis, including communicating directly with sales teams.
Coordination with customer care teams on replacement products and credits Provide updates within Trackwise on status of event detail information and product returns to support complaint handling.
Work with internal and external partners on the facilitation of movement of complaint return product.
International and domestic complaint entry. Generate various weekly, monthly, and quarterly reports.
Work with internal supporting teams on quality of data coming into post market.
Monitor, create and assign regulatory communications to quality specialist for resolution.
What You Need
Bachelor’s degree in Mechanical/ Biomedical/ Biotech Engineering.
3-6 years of relevant work experience.
Good analytical and problem-solving skills.
Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820) and Knowledge of ISO 14971
Experience on Complaint process
Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
Expert-level knowledge of current industry standards for New Product Development and risk management practices.
