Supervisor, Quality Systems (Complaint Management)

Requisition ID:  32194  

 

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.

 

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.

 

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. Consider joining our team and unlock your potential. 

Join our dynamic medical device company as a Supervisor of Quality Complaint Systems, where you'll play a pivotal role in ensuring the highest standards of product quality and customer satisfaction. In this position, you will oversee the management and resolution of customer complaints, ensuring compliance with regulatory requirements and driving continuous improvement initiatives. Your expertise will contribute to maintaining our reputation for excellence and safety, while collaborating with cross-functional teams to implement effective quality assurance strategies. If you have a keen eye for detail, strong analytical skills, and a passion for enhancing product quality, we invite you to be a part of our dedicated team committed to making a difference in healthcare.
 

ESSENTIAL DUTIES

• Supervisor responsibilities of local site Quality Specialist Complaint team for activities including but not limited to monitoring team metrics for complaint closures and aging, initial and on-going training and support activities for the team, HR related actions, performance reviews, and compensation reviews of team.
• Primary people leader for site resources performed along with coordinated cross-functional alignment with the supervisors at other complaint handling sites.
• Responsible for investigation, root cause analysis, and closure of assigned complaints including complaints involving complex system and/or adverse event issues.
• 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.
• Coordinate training opportunities for the team.
• Setting up of goals for the team members and timely evaluation of performance indicators.
• Coordinate in hiring of people whenever required and support on boarding of new associates.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Scientific/technical bachelor’s degree or, equivalent of education such as technical associate degree and experience sufficient to successfully perform the essential functions of the job may be considered.

 

Experience

Minimum 5 years’ experience in Quality Management Systems, ideally specific to complaints and adverse events.

 

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 commun