Senior Quality Specialist (Complaint Investigation)

Requisition ID:  33722  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

 

As a Senior Quality Specialist (Complaint Investigation), where your expertise will directly impact patient safety and product excellence. In this pivotal role, you'll collaborate across departments to ensure compliance with FDA, ISO, and global regulatory standards, lead corrective action initiatives, and support internal and external audits. With a focus on MDR reportable complaints and complex technical investigations, this position is ideal for professionals with experience in medical device quality systems. If you're passionate about improving lives through innovation and regulatory excellence, we invite you to be part of our mission-driven team.

 

ESSENTIAL DUTIES

• Works with quality management, manufacturing, engineering, and other functional groups on regulatory and quality system compliance issues.  Develops or participates in the development of solutions to problems of intermediate to high complexity. 
• Performs varied quality/regulatory activities such as developing and implementing plans and procedures to comply with applicable local, state, federal, and international regulations. 
• Interprets, executes, and recommends modifications to operating policies where appropriate.  Modifies, updates, and executes established programs to achieve and maintain a state of compliance.
• Contributes to or leads projects for the timely completion of corrective actions.
• Supports the implementation and maintenance of the Quality System.
• Provides support to the internal and external audit program.
• Leads and participates in continuous improvement.
• May participate in evaluation of complaints for adverse event reporting on a global basis and is responsible for submitting necessary reports for North America according to policies and procedures.
• May develop and maintain company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements and standards. 
• May assist or lead in identification, creation, implementation, and maintenance of training for QMS policies and procedures.
• May prepare and deliver presentations to management team.
• May direct supervision of professional and quality support staff including the review, evaluation, and development of reporting associates.

 

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

 

Experience

• Minimum 5 years experience.
• Experience with MDR reportable complaints (21 CFR 803) and requirements for report submissions.
• Experience with complex customer complaint investigation of a technical and medical nature.

 

Skills

• Able to orchestrate multiple activities at once under limited direction.
• Experience in process mapping.
• Strong knowledge of FDA and ISO regulations preferred.
• Ability to communicate effectively both verbally and in writing on a global basis.
• Working knowledge of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.