Assistant Manager - Quality Assurance

1. Position / Designation - Asst. Manager - Quality Assurance

2. Department - Quality

3. Supervisor - General Manager- QA & RA

4. Location - Bangalore

5. Age - 30 years & above

6. Academic Qualifications - Diploma or Degree (BSc or BE or B. Tech)

7. Experience (Years) - 10 years & above

8. Industries in which candidate has worked - Medical Device & Healthcare 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 QA & RA Manager and working collaboratively with other departments to define and execute functional and operational objectives.

Equipment Used

1. VMS, CMM, etc.

2. Minitab analysis software.

Key Accountabilities/Essential Functions

1. To ensure Raw Material / Packing Material and finished goods testing in line with the SOPs.

2. To establish & maintain documents for process validation.

3. Coordinating with cross-functional departments to complete tasks.

4. To prepare & review technical documents like DMR & DHR.

5. Work closely with staff to establish procedures, work instructions & reports.

6. Establish & maintain contact with external testing agencies.

7. Recording, analyzing and distributing statistical information.

8. Preparing quality documentation and reports by collecting, analyzing and summarizing information.

9. Supervising technical & laboratory staff.

10. Monitoring calibration activities.

11. Monitoring metrology activities & drawing reviews.

12. 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, DoE Analysis, etc.

4. Working knowledge of the 21 CFR Part 820, ISO 13485:2016 & ISO 9001:2015 standards.

5. Certified Internal Quality Auditor.

Personal Qualities/Characteristics required for the position

Very good written & verbal communication skills.

Good analytical and trouble shooting skills.

Good people management skills.