Senior Quality Engineer – ISO 13485 (Medical / Manufacturing)

Role Overview :

We are seeking an experienced Senior Quality Engineer with a strong background in ISO 13485 QMS implementation, CAPA management, supplier quality, validation and audit readiness . The ideal candidate must be someone with hands-on shop floor experience in a regulated manufacturing environment, preferably involving injection moulding, silicone moulding or precision component manufacturing .

The role demands someone who is practical, execution-driven, and highly knowledgeable about manufacturing processes , not just documentation.

Certifications and real manufacturing exposure are non-negotiable requirements.

The candidate should be able to independently manage, maintain and continuously improve a compliant ISO 13485 Quality System with end-to-end ownership.

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 & Required Skills :

Education

Experience

Technical Skills

Certifications — Mandatory / Non-Negotiable

Soft & Behavioural Skills

Performance Metrics

Ideal Fit