Quality Assistant -Implementing ISO 13485

Job Opening for Quality Assistant

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 & 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

Job Type: Full-time

Pay: ₹25,000.00 - ₹40,000.00 per month

Work Location: In person