Quality Assurance -Implementing ISO 13485

International Industrial Springs (IIS); Thane; On-site; INR 279,000 - 446,400; Full time

Job summary

International Industrial Springs (IIS) is looking for a Quality Assurance professional in Thane to implement and maintain ISO 13485 standards. You will be responsible for updating QMS documentation, leading audits, and conducting quality checks.

The ideal candidate has 3–5 years of experience in quality management, particularly in the medical device industry, and possesses strong documentation and organizational skills.

Qualifications

• Minimum 3–5 years of experience in Quality Management, preferably in the medical device industry.
• 4–5 years of experience in a quality or manufacturing environment is preferred.
• Strong knowledge of ISO 13485 and medical device regulations is an advantage.

Responsibilities

• Maintain, review, and update QMS documentation to ensure compliance.
• Lead internal audits and prepare documentation for external audits.
• Support and lead training sessions, maintaining training records.
• Conduct detailed QC checks and inspections independently.
• Track and analyze CAPA actions for timely closure.
• Manage supplier documentation and contribute to quality management.
• Ensure document control and compliance with ISO 13485.
• Promote awareness of quality procedures across departments.

Skills

QMS principles and ISO standards

Attention to detail

Organizational skills

Analytical skills

Communication skills

Microsoft Office proficiency

Education

Diploma or Bachelor in Mechanical Engineering or related field

Job description

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.

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