At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide.
With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.
The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.
Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally.
Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals.
Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.
Position Summary Responsible for preparing and implementing Quality System documentations necessary to comply with the applicable regulatory agency requirements.
Also responsible for ensuring compliance with Quality System regulatory requirements.
Support non-conformance product failure analysis, root cause investigations, quality control inspection activities and corrective/preventive action initiatives.
Responsible for oversight/management of the complaint investigation and reports.
Key Accountabilities: .
Interface with Research and Development and other engineering departments to determine whether process and/or product changes are needed based on field failure investigations.
· Participates in multiple product related activities including Design Reviews, updates of FMEA, audits, and editing standard production documentation
· Assure all responsibilities are carried out in compliance with Quality Systems (i.e.
ISO13485, 21CFR820), as well as all federal, state, and local government regulations
· Updates Quality Assurance procedures as necessary to comply with Quality System requirements (i.e.
ISO13485, 21CFR820).
· Assist in other areas of the Quality System not specified herein as needed.
Supports the complaint handling process by coordinating product returns and documenting complaints as they are received.
Responsible for the investigation of worldwide complaints, overseeing the complaint reporting and investigation process, and management of complaint-related metrics.
· Oversees complaint investigations
· Analyzes and prepares information on customer complaint investigations.
Provides follow-up actions as necessary.
· Coordinate corrective / preventive actions internally to ensure that all in-house and field failures are properly corrected and prevented from reoccurrence.
· Ensures Quality metrics related to complaints are reported monthly with strategies to address any metrics not meeting the goals.
Coordinate receipt and dissemination of complaint information, including return of the product for investigation
· Ensures timely completion of complaint reports and follow-ups.
· Ensures adequate investigation (with other departments if necessary) and adequate documented evidence of the root cause investigation(s).
· Ensures the proper documentation and implementation of any necessary corrective/preventive actions as a result of the complaint(s).
· Perform trending and statistical analysis for failures reported
· Periodically reports complaint trending data to management.
· Analyzes and investigates both in-house and field data, reports quality problems, recommends corrective action, and follows-up on the implementation and effectiveness of solutions.
· Updates any FMEA changes that result from Complaints as needed, based on the risk assessment.
· Provide customers with letter of the results of the investigation
· Suggests and implements improvements to Complaint Reporting systems.
· Must be able to assess Quality System records for trends and recommend appropriate changes to sampling plans, inspections methods, and/or tooling.
· Must be able to perform training to Quality Assurance standards, operating procedures, inspection and test procedures.
Internal Networking/Key relationships: This position requires cooperating with different departments, such as R&D, Regulatory, Operations, Sales, Marketing, and the other team members of the department Minimum Skills and Capabilities:
· Excellent Written and Verbal Communication
· Ability to interact with all levels within organization
· Excellent analytical skills and ability to analyzed trending data into recommendations for improvements or preventive actions
· Mechanically inclined
· Computer and software skills including all Microsoft Office applications
· Ability to motivate others and improve efficiency
· Understanding of quality system regulations (ISO 13485, 21 CFR 820, MDD, Japanese MHLW) and any other international regulations, as applicable.
· Sit/Stand/Walk 8 hours per day
· Light lifting
· Demonstrate leadership; attention to detail and ability to solve problems and communicate issues
· Ability to work in different and multiple projects/reports
· Ability to do research and come up with creative solutions for CAPA challenges Minimum Knowledge & Experience required for the position:
· BS in Engineering or Related Field
· 3 Years of Medical Device Manufacturing or Quality experience
· Understanding of quality system regulations (ISO13485, 21CFR820)
· Prior experience in a lead Complaint role (administration function) of a Medical Device Manufacturing preferred, but will consider recent graduates with relevant qualifications for Complaint role
· Knowledge of FDA & ISO requirements with regard to Complaint processes and administrative functions is strongly preferred International Mobility: Not required.
Travel requirements: 10%