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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