Quality Assurance -Implementing ISO

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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