Quality Complaint Specialist

Requisition ID:  31918  

 

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. 

We are seeking a meticulous individuals with a passion for investigating complex complaints to ensure the safety and efficacy of medical devices. In this role, you will play a pivotal part in analyzing adverse events, conducting thorough root cause analyses, and collaborating with cross-functional teams to implement effective solutions. If you are detail-oriented, analytical, and committed to upholding regulatory standards in the healthcare industry, we invite you to apply and be a part of our mission to improve patient outcomes and product quality. 

 

ESSENTIAL DUTIES

• Lead investigator responsible for authoring and investigating Adverse Event Reportable Complaints which may result in  Field Action Evaluation decisioning.
• Supports in performing Literature Searches and evaluation of results for determination of complaint initiation and investigation.
• Works both independently and collaboratively to accomplish established objectives and performs varied quality/regulatory activities such as investigation and coordination of customer product quality complaints, physical evaluation of returned goods which may contain blood product, and performance of regular quality system audits.
• Partners closely with manufacturing, engineering, and other functional groups on regulatory compliance issues.  Develops or participates in the development of solutions to problems of moderate to intermediate complexity.  Interprets, executes, and recommends modifications to operating policies where appropriate.
• Provides accurate and timely turnaround time on complaints, returned goods, trend reports, and other activities.  Maintains related reports that are accurate and concise.
• Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives and recommending solutions.
• Follows department processes and regularly makes recommendations on these processes.
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
• Designs and performs routine testing, project experiments, and analysis of data on an independent basis. Reports results.
• Fulfills FDA and international regulatory requirements relevant to each project such as GMP, IDE, PMA, 510(k), and ISO.
• Coordinates product builds, documentation, and release activities.
• Extreme focus to the end customer.
• Flexible schedule to accomplish primary customer.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Bachelor Degree in Engineering (preferably Chemical) or Microbiology.

 

Experience

Minimum 5 years experience in quality-related role within a pharmaceutical/medical device manufacturing environment.

Clinical apheresis experience preferred.

 

Skills

• Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques.
• Knowledge of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Continuous development of knowledge in physical, life sciences, or engineering theory and practice as this knowledge applies to each project.
• Knowledgeable in FDA and international regulations relevant to each project, i.e., GMP, IDE, PMA, 510(k), and ISO.
• Work assignments require the development of in-depth engineering or technical skill(s) or breadth.
• Knowledge of relevant PC software applications (SAP, Windchill, SalesForce) and skills to use them effectively.
• Proficient in Microsoft Excel, Word, and Teams.
• Excellent interpersonal and communication (written and verbal) skills from a global perspective.

-Or-

 

An equivalent competency level acquired through a variation of t