Quality Engineer

6 days ago

Wagle Estate Thane Maharashtra, India Aakar HR Consultant Services Full time ₹ 2,00,000 - ₹ 6,00,000 per year

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).

· Candidate must be from a medical/Pharma background company with hands-on experience in ISO 13485 certification and compliance.

· Familiarity with 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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