Process Quality Engineer

Role Overview

We are looking for a highly disciplined Process Quality Engineer to own and maintain all quality, regulatory, and compliance frameworks across the company. This role is central to ensuring that every product—hardware, embedded systems, software, and instrumentation—meets ISO, GMP, CE, and other relevant international standards.

You will be the custodian of quality documentation, process integrity, audits, risk analysis, and corrective actions across the entire product lifecycle: design, manufacturing, testing, calibration, and field deployment.

Key Responsibilities

1. Standards & Compliance Management

• Maintain, update, and enforce compliance with:
• ISO 9001 (Quality Management Systems)
• ISO Medical Device Quality Systems), where applicable
• GMP requirements for medical/diagnostic instrumentation
• CE documentation (technical files, risk assessment, EMC/Safety test data) for all products
• Any additional regulatory frameworks (AERB, BIS, IEC, RoHS, FCC where applicable)

2. Documentation Control

• Own and maintain all Quality System Documents (QSD) including SOPs, Work Instructions, Process Flow Charts, QMS forms, NCR logs, calibration logs, device history records (DHR), device master records (DMR), etc.
• Create, update, and control documentation for each product line (HFCM, XSpec, DetecX, SiPM modules, FPGA boards, dosimeters, etc.).
• Ensure revision control, document traceability, and version management.

3. Manufacturing Process Quality

• Establish and maintain incoming, in-process, and final QC procedures.
• Validate and optimize processes for PCB assembly, calibration workflows, high-voltage testing, sensor verification, and environmental testing.
• Implement sampling plans, inspection criteria, and statistical quality control (SPC).
• Audit suppliers for component and assembly quality.

4. Product Certification Support

• Prepare and maintain CE Technical Documentation for each product:
• Essential Requirements Checklist
• Risk Assessment (ISO 14971)
• EMC and Electrical Safety test documentation
• BOM traceability, labeling conformity, DoC (Declaration of Conformity)
• Coordinate with external labs for EMC, EMI, ESD, environmental, and safety testing.

5. Quality Audits

• Plan and execute internal quality audits.
• Coordinate external audits and surveillance visits (ISO auditors, notified bodies, regulatory agencies).
• Drive CAPA (Corrective and Preventive Actions) to closure with engineering and production teams.
• Ensure audit findings are documented, tracked, and verified.

6. Risk Management & Failure Analysis

• Perform FMEA for processes and products.
• Lead investigations for field failures, RMAs, device malfunctions, and non-conformities.
• Work closely with engineering and manufacturing to implement corrective actions.

7. Training & Process Enforcement

• Train staff on SOPs, QC procedures, documentation discipline, and regulatory requirements.
• Ensure cross-department adherence to quality processes.
• Promote a culture of continuous improvement.

Required Qualifications

• Bachelor's degree in Mechanical, Electronics, Industrial Engineering, or related field.
• 2–5 years experience in Quality Engineering (medical devices, electronics, instrumentation, or similar industries preferred).
• Strong understanding of ISO/GMP/CE and regulatory compliance documentation.
• Experience with risk assessment tools (FMEA, Fault Tree Analysis, etc.).
• Familiarity with calibration procedures, QC instrumentation, and production workflows.
• Excellent documentation, organizational, and reporting skills.

Preferred Skills

• Experience with EMC/EMI testing and CE certification processes.
• Knowledge of AERB/BIS/IEC safety standards (for nuclear/medical instrumentation).
• Understanding of PCB manufacturing, embedded systems, FPGA/controller hardware, and sensor devices.
• Working knowledge of statistical tools (SPC, Minitab, JMP, etc.).
• Ability to read schematics, BOMs, and mechanical drawings.

What We Offer

• Opportunity to shape the quality backbone of an advanced instrumentation company.
• Work across multiple innovative product lines in nuclear medicine, radiation safety, and precision electronics.
• Fast-paced environment with autonomy, responsibility, and growth potential.
• Competitive salary and performance-based incentives.

Job Type: Full-time

Pay: ₹216, ₹468,260.35 per year

Benefits:

• Provident Fund

Work Location: In person