Supplier Quality Assurance

Job Description

Role – Supplier Quality Assurance & Procurement supplier engineer

Job Summary

Driving supplier quality excellence across dialysis and cardiovascular devices, enabling regulatory success, cost optimization, and robust global supply chains to support life-saving medical innovations.

Key Responsibilities:

-Supplier Qualification & Audits

Lead end-to-end supplier qualification and approval

On-site supplier audits (process & system audits)

Compliance audits aligned with applicable regulatory requirements

Develop and maintain Approved Supplier List (ASL)

-NPI & Supplier Development

Partner with R&D and engineering teams for:

New product development (Dialysis, PTCA, TAVI)

Design transfer to suppliers

Process validation (IQ / OQ / PQ)

Supplier readiness for commercial production

-Quality Performance Management

Establish and track supplier KPIs:

Incoming quality (PPM, defect rates)

Field failures & returns

On-time delivery (OTIF)

Lead:

Root Cause Analysis (8D, 5 Why, Fishbone)

Corrective & Preventive Actions (CAPA)

-Risk Management & Mitigation

Conduct:

Supplier risk assessments (FMEA, risk-benefit analysis)

Identify and mitigate:

Single-source dependencies

Quality and supply risks in critical components

-Technical Oversight (Critical Components)

Provide expertise in:

Dialysis fluidics systems (pumps, solenoid valves, tubing)

Cardiovascular devices (PTCA catheters, TAVI systems)

Polymer processes (extrusion, injection molding, bonding)

-Cost & Localization Initiatives

Support strategic sourcing and localization programs

Enable cost optimization through supplier development and design collaboration

Drive make vs buy decisions using structured evaluation

-Change Control & Documentation

Manage:

Engineering Change Requests (ECR/ECO) related to suppliers

Supplier change notifications and approvals

Ensure:

Full traceability and documentation compliance

-Cross-functional Leadership

Act as the bridge between Quality, Procurement, R&D, and Regulatory teams

Drive alignment on:

Quality standards

Launch timelines

Supplier readiness

Location

India / Global (Travel Required)

Experience

10+ years in Medical Device Industry

Required Skills & Experience

Strong experience in Hemodialysis systems and cardiovascular devices (PTCA / TAVI)

Hands-on FDA audit and submission experience

Knowledge of fluidics (pumps, valves), catheter systems, polymers

Expertise in supplier quality, audits, and regulatory compliance

Strong analytical and problem-solving ability

Key Competencies

Leadership & Stakeholder management

Supplier Development

Risk-Based Thinking

Data-driven decision making

Continuous improvement

Qualifications and Experience:

• 10 + Years experience in program management in NPI procurement quality managing supplier for medical devices with focus on sourcing strategies for Mechatronics & mechanical for New product in medical industry.
• B.E. in Mechanical engg./Electronics engg. /M tech in Quality systems & Mechatronics.