Position Vacant

Quality Assurance -Implementing ISO 13485

Department

Quality

Location

Thane

Work Experience

Minimum 3–5 years of experience in Quality Management, preferably in the medical device industry.

Job Opening for Quality Assurance

Pay: 25,000.00 - 40,000.00 per month

Job Description

Key Responsibilities:

Maintain, review, and update QMS documentation (SOPs, Work Instructions, Records) to ensure accuracy and compliance.
Lead coordination of internal audits and prepare comprehensive documentation for external audits.
Support and sometimes lead training sessions, maintaining and updating training records.
Conduct detailed QC checks and inspections independently, ensuring adherence to quality standards.
Track, analyze, and follow-up on CAPA actions, driving timely closure.
Manage supplier documentation and contribute to supplier quality management and risk assessment activities.
Ensure robust document control and record retention in strict compliance with ISO 13485.
Promote and enforce awareness of quality procedures across departments, offering guidance to junior team members.

Qualifications

Qualifications & Experience:

Diploma or Bachelor s in Mechanical, Engineering, or related field.
4–5 years of experience in a quality or manufacturing environment (preferred).
Strong knowledge of ISO 13485 and medical device regulations is an advantage.

Skills Required

Solid understanding of QMS principles and ISO standards.
Excellent attention to detail and ability to maintain documentation accuracy.
Strong organizational, analytical, and communication skills.
Proficient in Microsoft Office (Word, Excel, Outlook).
Ability to work independently, take ownership of tasks, and collaborate effectively within a team.

Job Type: Full-time

Work Location: In person

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