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19/11 Aayushi Verma
HR Consultant - Talent Acqusition at Biopeople India

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Quality Assistant - Manufacturing Sector (2-5 yrs)

Thane Job Code: 43478

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 closur

- 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.

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