Engineer - QA
Terumo Penpol · Thiruvananthapuram · onsite · Posted 42d ago
Undisclosed2–7 yrsfulltimeSourced from
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About this role
35463
At Terumo Blood and Cell Technologies, our 8,000+ 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/Trainee 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.
E SSENTIAL 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 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.
- 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.
- Demonstrate extreme focus to the end customer.
- Run trends from established database for communication or product improvement activities.
- NEW: Performs complaint review, classification, prioritization, triage, and escalation assessments based on product risk and regulatory requirements.
- NEW: Conducts and documents root cause investigations using 5-Why Analysis, Fishbone Analysis, Fault Tree Analysis, and Failure Mode Analysis techniques
- NEW: Reviews returned product evaluations, failure analysis results, and device inspection findings to support investigation conclusions.
- NEW: Supports ISO 14971 risk management activities including hazard identification, risk evaluation, and risk file updates resulting from complaint investigations.
- NEW: Supports Post-Market Surveillance (PMS) activities through complaint trending, signal detection, and adverse event monitoring.
- NEW: Identifies and escalates complaint investigation outputs requiring CAPA initiation and supports CAPA effectiveness activities.
- NEW: Ensures complaint handling compliance with 21 CFR 820 complaint requirements, MDR regulations, ISO 13485, EU MDR vigilance, and applicable global regulations.
- NEW: Performs complaint data analytics and statistical trending to identify recurring issues, emerging signals, and product improvement opportunities.
- NEW: Collaborates with Manufacturing, Engineering, Regulatory Affairs, Clinical, Supplier Quality, and other SMEs during complex investigations.
MINIMUM QUALIFICATION REQUIREMENTS
Education
- Bachelor Degree in Engineering (preferably Mechanical / Electrical / Electronics)
Experience
- Preferably min one year experience in medical device manufacturing environment and/or previous experience in Post Market Compliance
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.
- 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.
Job Segment: R&D Engineer, QA Engineer, Manufacturing Engineer, Medical Device Engineer, Medical Device, Engineering, Healthcare
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
CfrISO 13485Complaint managementcustomer feedbackcorporate social responsibilityclassificationHazard identificationCAPABlood CollectionAnalyticsGood Laboratory PracticeData AnalyticsHealthcarecomplianceComplaint Handling
About Terumo Penpol
Terumo Penpol
Medical Equipment
295
employees
1983
43 years old
Hyderabad,Telangana
India
₹7.1L PA avg
Avg at Terumo Penpol
About
Terumo Penpol focuses on blood management solutions, supplying advanced technology and manufacturing to enhance transfusion practices globally.
Industries
Medical EquipmentInternet
Employee ratings
10 reviews
4.6/ 5
Culture
4.0
Career growth
3.5
Work-life
4.2
Employees rate it well for
Overall Company46Work-Life Balance44
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