Location: Elkton,MD, USA
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
Job Summary
The Complaint Handling Specialist I is responsible for analyses and control of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR) and other regulatory guidelines. Facilitates all complaint investigation activities with cross functional team members and prepares complaint investigation reports. Responsible for assisting with the inspection and testing of retention and return samples and summarizing the findings to support complaint investigations.
Job Details/Responsibilities
* Investigates customer complaints daily related to product quality and patient safety. Log complaints in the complaints software system and support in their investigation.
* Support in the testing of returned samples and assist in the review of Device History Records.
* Maintains oversight of the complaints and daily processes to ensure issues are being addressed in a timely and thorough manner and conform to complaint policy and procedures.
* Performs investigative tasks to support in the determination of root cause and resolution of identified complaints. This includes interactions with appropriate stakeholders including but not limited to customers, medical professionals, field staff and Terumo affiliates to obtain information pertinent to investigations.
* Assemble and send laboratory packs to customers in a timely manner.
* Assisting with decontaminating and testing of returned and retention products
* Works closely with Complaints Engineering, Quality Engineering, and support departments to complete complaint analysis and document investigation results.
* Makes Adverse Event Reportability decisions in accordance with US and International regulations in collaboration with Quality Engineering, Complaints Engineering and Compliance functions.
* Assists with generation of Medical Device Reports (MDRs) and Vigilance Reports as required.
* Assists in preparing responses to customers and field as necessary per process.
* Assists in providing training and guidance on reporting regulations.
Knowledge, Skills and Abilities (KSA)
* Requires a minimum 2 years experience in a quality or customer service/complaint resolution in medical device industry (disposable devices).
* Thorough knowledge of standards and regulations for medical devices.
* Strong analytical and problem solving skills.
* Excellent written and oral English communication skills required.
* MS Office (Word, PowerPoint, Excel) experience required.
* Ability to interact with individual and groups at all levels.
* Good presentation/training skills required.
* Mathematical knowledge including algebra/statistics; utilization of sampling plans and statistical charts.
* Typically requires a logical thought process and decision making ability.
* Ability to use testing equipment.
* Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
* Ability to identify priorities and function independently required.
Qualifications/ Background Experiences
* Requires a high school diploma; post high school is beneficial.
* An Associate's Degree in science / healthcare or equivalent technical degree is preferred.
It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.