Quality Engineer – ISO 13485 / Quality Systems

Candidate from Hyderabad and Pune or someone willing to relocate are preferred.

Summary

We are seeking an experienced Quality Engineer with a strong background in ISO 13485 quality-management systems to support our growing manufacturing operations. The ideal candidate will be proficient in QMS implementation, CAPA management, supplier quality, and process validation within a regulated environment. Experience with injection molding or precision component manufacturing is highly desirable, but the key requirement is the ability to manage and maintain a compliant, efficient, and audit-ready ISO 13485 QMS.

Key Responsibilities

Quality System & Compliance

• Maintain and improve the company’s ISO 13485-compliant QMS, ensuring documentation control, change management, and risk analysis meet regulatory expectations.
• Lead internal audits, management reviews, and support external audits (ISO registrar and customer).
• Ensure compliance with ISO standards and customer-specific requirements.
• Develop, revise, and approve quality procedures, forms, and records.

CAPA & Non-Conformance Management

Validation & Process Qualification

Supplier Quality

Measurement, Inspection & Calibration

Documentation & Reporting

Qualifications

Education :

Experience :

Technical Skills :

Certifications (Preferred) :

Soft Skills :

Performance Metrics :