Quality Engineer – Trainee Engineer
Terumo Blood and Cell Technologies
full-time
Posted on:
Location Type: Office
Location: Thiruvananthapuram • 🇮🇳 India
Visit company websiteJob Level
Entry Level
About the role
- Investigation and co-ordination of customer product quality complaints
- Prepares Medical Device Reports/Adverse Event Reports (MDRs/AERs) adhering to FDA regulations
- 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
- Prepares and reviews engineering/technical documents such as Reports, SOP’s, Work Instructions and process documents
- Follows department processes and regularly makes recommendations on these processes
- Works cooperatively and effectively in a team environment or across teams
- Actively participates in Quality System and Good Laboratory Practice requirements
Requirements
- Bachelor Degree in Engineering (preferably Mechanical/Electrical/Electronics)
- Preferably min one year experience in medical device manufacturing environment
- Knowledge and use of relevant PC software applications like SAP, Windchill, SalesForce
- Exposure to Excel, Word, Sharepoint and Teams
- 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
- Understanding of and adherence to GMP practices and FDA regulations
- Knowledge of EU MDR, FDA, ISO regulations preferred
Benefits
- 25 days annual leave
- Health insurance
- Flexible working hours
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Medical Device ReportsAdverse Event Reportscomplaint investigationengineering documentsSOPsWork Instructionsfailure mode analysisstatistical toolscontinuous improvement techniquesmanufacturing protocols
Soft skills
teamworkproblem diagnosisrecommendation of solutionseffective communicationcooperationtimelinessattention to detailprocess improvementanalytical thinkingparticipation