Quality Engineer
SMC Ltd
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- Location
- Bangalore, United States
- Posted
- Nov 5
- 2 days ago
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About the company
SMC Ltd
Medical devices · 501 to 1,000 employees
What you'll do
- Ensure Raw Material / Packing Material and finished goods testing in line with the SOPs
- Maintain device history records (DHR) & product release checklist for each lot
- Conduct inspections at in-process, in-coming and completes the final inspections
- Prepare technical documents like DMR & DHR
- Maintain microbial record in ISO class-7 & class-8 as per procedure
- Prepare control plan, FMEA & FAIR documents
- Monitor calibration activities
- Perform metrology activities & drawing reviews
What you need
- Degree/Diploma in Mechanical Engineering (preferred)
- 2 to 6 years (preferred)
- Good communication skills in English (spoken & written)
- Good technical, analytical and trouble shooting skills
- Working knowledge of the ISO 13485 & ISO 9001standards
- Preferred skills in various metrology equipment, such as VMS, CMM programming, etc.
- Medical device, healthcare & automobile industry experience (preferred)
- Age: 22 to 28 years (preferred)
- Education: a bachelor's degree or an associate degree
Key skills
CMM programmingMinitab softwareroot cause analysisProduct & process validationGauge R&RCpKPpKIQ, OQ,PQ validation/qualificationMSAISO 13485FAIR inspectionDHRcontrol of documents
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Read the full posting here
1. Position/Designation : Quality Engineer
2. Department : Quality
3. Supervisor : Asst. Manager - QA
4. Location : Bangalore
5. Age : 22 to 28 years preferred
6. Academic Qualifications : Degree/Diploma in Mechanical Engineering is preferred
7. Experience (Years) : 2 to 6 years preferred
8. Industries in which candidate has worked : Medical device, healthcare & automobile industry, preferably.
9. Supervision of People : Yes
10. Communication and Presentation Skills : Good communication skills in English (spoken & written).
Position Scope & Purpose
This position reports to the Asst. QA Manager and working collaboratively with other departments to define and execute functional and operational objectives.
Equipment Used
1. VMS, CMM, Vernier caliper, micrometer, height gauge, etc.
2. Minitab software.
Key Accountabilities/Essential Functions
1. To ensure Raw Material / Packing Material and finished goods testing in line with the SOPs.
2. To maintain device history records (DHR) & product release checklist for each lot.
3. To conduct inspections at in-process, in-coming and completes the final inspections.
4. To prepare technical documents like DMR & DHR.
5. To maintain microbial record in ISO class-7 & class-8 as per procedure.
6. Creating master documents to track calibration & latest version of documents and records.
7. To prepare control plan, FMEA & FAIR documents.
8. To prepare 8D and supplier CAPA reports.
9. Monitoring calibration activities.
10. Perform metrology activities & drawing reviews.
11. Coordinates investigation, root cause analysis & corrective action.
Technical/Functional Skill Sets
1. Preferred skills in various metrology equipment, such as VMS, CMM programming, etc.
2. Product & process validation requirements & implementation.
3. Gauge R&R, CpK, PpK studies, IQ, OQ,PQ validation/qualification, MSA, run charts, etc.
4. Working knowledge of the ISO 13485 & ISO 9001standards.
5. FAIR inspection, DHR & control of documents.
Personal Qualities/Characteristics required for the position
Good technical, analytical and trouble shooting skills.