Assistant Manager - Quality Assurance

1. Position / Designation

• Asst. Manager
• Quality Assurance

1. Department

• Quality

1. Supervisor

• General Manager- QA & RA

1. Location

• Bangalore

1. Age - 30 years & above
2. Academic Qualifications

• Diploma or Degree (BSc or BE or B. Tech)

1. Experience (Years) - 10 years & above
2. Industries in which candidate has worked

• Medical Device & Healthcare Industry, preferably.

1. Supervision of People

• Yes

1. 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
3. To ensure Raw Material / Packing Material and finished goods testing in line with the SOPs.
4. To establish & maintain documents for process validation.
5. Coordinating with cross-functional departments to complete tasks.
6. To prepare & review technical documents like DMR & DHR.
7. Work closely with staff to establish procedures, work instructions & reports.
8. Establish & maintain contact with external testing agencies.
9. Recording, analyzing and distributing statistical information.
10. Preparing quality documentation and reports by collecting, analyzing and summarizing information.
11. Supervising technical & laboratory staff.
12. Monitoring calibration activities.
13. Monitoring metrology activities & drawing reviews.
14. 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.