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
