Assistant Manager - Quality Assurance

SMC Ltd; Bengaluru; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

SMC Ltd. invites applications for the position of Assistant Manager - Quality Assurance in Bengaluru. The role reports to the QA & RA Manager and requires collaboration with multiple departments to meet functional objectives.

Ideal candidates have 10+ years in QA within the medical device/healthcare sector, with strong English communication and staff supervision experience. Proficiency in Minitab and adherence to 21 CFR Part 820 / ISO standards is preferred.

Qualifications

• 10+ years of QA experience in medical devices/healthcare.
• Diploma or Degree in science or engineering (BSc/BE/BTech).
• Strong English communication (spoken & written).
• Experience supervising staff and coordinating teams.

Responsibilities

• Test raw materials, packing materials and finished goods per SOPs.
• Establish and maintain documents for process validation.
• Coordinate with cross-functional teams to complete tasks.
• Prepare and review DMR and DHR documentation.
• Develop procedures, work instructions and reports with staff.
• Liaise with external testing agencies for testing and verification.
• Record, analyze and distribute statistical information.
• Prepare quality documents and summarize information in reports.
• Supervise laboratory staff and monitor calibration activities.
• Coordinate investigations, root-cause analysis and corrective actions.

Skills

Communication

Analytical skills

Troubleshooting

Documentation

Education

Diploma or Degree (BSc/BE/BTech)

Tools

Minitab analysis software

Job description

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

2.Department - Quality

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

• 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.
• 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.
• 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.