Assistant Manager - Quality Assurance
Summary
Assistant Manager of Quality Assurance at a medical device manufacturer in Bangalore: oversees raw material/packaging and finished-goods testing, process validation and quality documentation (DMR/DHR), calibration and metrology, and supervises lab staff, using VMS/CMM and Minitab under ISO 13485 / 21 CFR Part 820 quality systems.
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.