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Engineer - QA

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Date: Apr 27, 2022

Location: Thiruvananthapuram, KL, IN

Company: Terumo BCT, Inc.

Requisition ID:  29095  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates are 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.

 

JOB TITLE: Quality Engineer

 

Department : Global Complaint Management

 

JOB SUMMARY

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor adaptations and modifications.  Assignments include Quality Process execution, research for investigations, report preparation and other activities of limited scope.  Duties are assigned to provide experience and familiarization with quality, compliance and engineering methods, independent thinking, and company practices and policies.

 

 

ESSENTIAL DUTIES

  • Investigation and co-ordination of customer product quality complaints both Normal priority and High Priority .
  • Prepares Medical Device Reports/Adverse Event Reports(MDRs/AERs) adhering to FDA regulations in a timely manner.
  • Enters complaint and routine service records both manually and by uploading spreadsheets into the quality system application .
  • Provide accurate and timely turn-around on complaints and other activities.  Maintain records that are accurate and concise. 
  • Generates Customer Feedback Letters extracted from Complaint Investigation and effectively collaborate with other teams to the answer the queries raised by customer.
  • Prepares and reviews engineering/technical documents such as Reports, SOP’s, Work Instructions  and process documents.
  • Takes initiative and demonstrates inquisitive approaches to learn new things
  • Shall Perform tasks of non-reportable complaint of low technical risk.
  • Able to complete basic technical write ups and general  complaint documentation
  • Applies standard solutions to complaints of routine nature by carrying out written or oral instructions
  • May contribute ideas and/or concepts that support the generation of products and processes.
  • Seeks guidance while carrying out instructions furnished in written or verbal form and takes task approach
  • 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.
  • Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation.
  • Run trends from established database for communication or product improvement activities
  • Demonstrates extreme focus to the end customer.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

  • Bachelor Degree in Engineering (preferably Mechanical/Electrical/Electronics) or any technical graduations equivalent to it.

 

 

Experience

  • Have a minimum of two years’ experience in a quality-related role within a pharmaceutical/medical device manufacturing environment

 

Skills

  • Knowledge and use of relevant PC software applications like SAP, Windchill, SalesForce and skills to use them effectively. Exposure to Excel,Word, Sharepoint and Teams.
  • Excellent interpersonal and communication (written and verbal) skills from a global perspective.
  • Must be able to translate or have translated by local representation, all regional complaints and routine service reports into technically accurate English text
  • Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques.
  • Self-directed individual with the ability to perform essential functions independently in future
  • Knowledge of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
  • Ability to be extremely detail oriented while working with high volumes of records
  • Intense focus on providing support to internal and external customers in a timely manner.
  • Work in conjunction with manufacturing, engineering and other functional groups on regulatory compliance issues
  • Interfaces with staff  and external subject matter experts to resolve technical issues
  • Understanding of and adherence to GMP practices and FDA regulations and ability to implement FDA or regulatory requirements as necessary.
  • Knowledge of EU MDR, FDA, ISO regulations preferred.

 

Terumo Penpol is part of Terumo Group and is headquartered in Thiruvananthapuram, Kerala. As India’s largest blood bag manufacturer, we provide a comprehensive range of blood collection, storage and processing solutions for blood centers, hospitals and therapeutic apheresis centers in India and abroad. Our high-quality products touch the lives of patients in over 80 countries across the world.

 

True to our mission of contributing to society through healthcare, our award-winning Corporate Social Responsibility initiatives reinforce our organizational values and culture. Firmly rooted in core values collectively termed as the ‘Associate Spirit’, our work culture fosters an environment conducive to growth and continuous learning. People are our greatest asset, and we place as much importance in their professional development as in the research and development of our products.


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