Conduct complaint investigation management and all activities pertaining to product complaints for Mechanical Circulatory Support devices.
Receiving and investigating reports of worldwide complaints/events
Entering information into the complaint database
Supporting filing and response to medical devices reports with various regulatory agencies
Participating on cross-functional teams
Providing information on product complaints, including data extracted from the complaint database to various teams (e.g. Regulatory, Quality Engineering).
Expand development in the area of quality engineering methodologies and providing quality engineering support within new product development, manufacturing, manufacturing transfers, and/or system/services support.
Communicates verbally and in writing both internally and externally regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file
Investigates complaints/events in a timely manner
Maintains accurate entry of complaints in database
Records condition of returned products including observations, photographs
Coordinates product testing/analysis with other departments and external consultants
Prepares technical reports of analysis/findings
Tracks returned products within the database, as appropriate.
Works collaboratively with cross-functional groups (e.g. QEs, R&D) on evaluation trends or findings
Interprets technical product specifications, Device History Records, or measurements obtained
Utilizes safe bio-hazard and chemical handling practices at all times
Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, rapid customer response team, Risk Management meetings)
Lead the investigation, resolution and prevention of product and process nonconformances
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
Lead in the completion and maintenance of risk analysis
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
BS degree in Electrical Engineering, Biomedical (if they have electrical experience)
0-2 years’ experience
Must have strong critical thinking skills
Strong written and oral communication skills are required.
Able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
Advanced computer skills, including statistical/data analysis and report writing skills
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Engineering experience preferred
Knowledge of global regulations for medical device reporting and medical terminology is a plus
Experience working in a broader enterprise/cross-division business unit model preferred.