:: Career ::

Position Vacant
Quality Engineer -Implementing ISO 13485

Department
Quality

Location
Thane

Work Experience
1- 2 Year Experience


*Job Description for a QC Assistant*

*Key Responsibilities:*

* Assist in maintaining and updating QMS documentation (SOPs, Work Instructions, Records).

* Help coordinate internal audits and prepare documentation for external audits.

* Support the training process by organizing sessions and maintaining training records.

* Perform basic QC checks and inspections under supervision.

* Assist with tracking and follow-up on CAPA actions.

* Help maintain supplier documentation and support risk management files.

* Ensure proper document control and record retention in compliance with ISO 13485.

* Promote awareness of quality procedures across departments.


**Qualifications & Experience:**

* Diploma or Bachelor s in Mechanical, Engineering, or related field.

* 1–2 years of experience in a quality or manufacturing environment (preferred).

* Familiarity with ISO 13485 and medical device regulations is an advantage.


Skills Required:

* Basic understanding of QMS principles and ISO standards.

* Good attention to detail and documentation accuracy.

* Strong organizational and communication skills.

* Proficient in Microsoft Office (Word, Excel, Outlook).

* Ability to follow procedures and work collaboratively in a team.


Job Type: Full-time

Work Location: In person


 

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