Senior QA Engineer

Job Title: Senior QA Engineer

Experience: 5- 10 Years

Location: Kandivali(Mumbai)

Role & responsibilities :

Key Technical Responsibilities

1. Electronics, Automation & Control Systems

• Work extensively with PLCs, control systems, industrial automation tools, and automated inspection machinery.
• Support integration of sensors, actuators, motor controllers, and machinelevel electronics.

2. Track & Trace / Serialization Systems

• Manage and validate serialization and trackandtrace systems for product authentication and regulatory compliance.
• Perform functional testing, data integrity checks, and system validation for T&T software and hardware components.

3. Vision Inspection Systems

• Handle vision cameras, scanners, optical inspection units, and highspeed imaging systems.
• Configure, validate, and troubleshoot vision algorithms, camera setups, lighting configurations, and defectdetection workflows.

4. Printers & Coding Equipment

• Validate and maintain industrial printers (TIJ, CIJ, laser, thermal, labelers).
• Ensure coding and marking systems meet quality, serialization, and regulatory requirements.
• Perform print quality validation, alignment checks, and software configuration.

5. Software, Databases & Compliance

• Strong working knowledge of MySQL and MS SQL including queries, data validation, troubleshooting, and data integrity.
• Ensure compliance with 21 CFR Part 11 (Electronic Records & Signatures) and data integrity principles.
• Collaborate with IT for access control, audit trails, backups, and cybersecurity compliance.

Quality & Validation Responsibilities

1. Test Case Preparation & Verification

• Prepare detailed test cases, test scripts, and validation documents for inspection systems, PLC logic, vision systems, and automation tools.
• Execute FAT, SAT, IQ, OQ, PQ, and system-level testing.

2. Validation & Qualification

• Lead validation for machines, software, databases, PLCs, vision systems, printers, and inspection equipment.
• Perform process validation, equipment qualification, test method validation, and data integrity validation.

3. ISO & Regulatory Compliance

• Ensure compliance with ISO standards (ISO 9001, ISO 13485 where applicable).
• Maintain documentation as per cGMP, QMS, and regulatory requirements.

4. Documentation & Quality Systems

• Create, review, and maintain validation protocols, reports, SOPs, URS, work instructions, and risk assessments.
• Ensure proper documentation in QMS systems.

System Installation, Service & Support

1. System Installation & Commissioning

• Install, configure, and validate systems including cameras, lighting, printers, sensors, and electronic modules.
• Perform OS installation, application deployment, and system setup at customer sites.
• Conduct acceptance testing and ensure system readiness.

2. Troubleshooting & Service Support

• Provide onsite and remote support for hardware, firmware, and software issues.
• Perform root cause analysis (RCA) and implement corrective actions.
• Reproduce issues in test environments for detailed investigation.

3. Software, Database & Tools Expertise

• Work with MySQL for configuration, logs, query handling, and data validation.

• Track issues using JIRA or similar tools.

• Perform scripting and automation using Python.

• Use automation/testing tools such as:

• Sikuli

• TestComplete

• Selenium

• Katalon Studio

4. Inspection System Management

• Configure and optimize:

• Camera settings

• Vision algorithms

• Print and verification systems

• Track & Trace modules

• Ensure compliance with GMP, ISO and customer audit requirements.

5. Documentation & Reporting

• Prepare and maintain:

• IQ, OQ, PQ documents

• Service reports and RCA documents

• Change logs, technical manuals, and SOPs

6. Customer Interaction & Site Visits

• Conduct site visits for servicing, preventive maintenance, audits, and upgrades.
• Train operators and customer engineers.
• Provide feedback to R&D for product improvements.

7. Cross-Functional Collaboration

• Work with Dev, QA, Software, and Product teams to resolve issues.
• Participate in testing, field trials, and new product validation.

Team Leadership & Collaboration

• Lead and mentor engineers, technicians, and inspectors.
• Coordinate with Production, Engineering, Quality, and Regulatory teams.
• Provide training on systems, validation, and data integrity.
• Drive continuous improvement using structured problemsolving.

Required Skills & Qualifications

Technical Skills

• Strong knowledge of electronics, embedded systems, and firmware behavior

• Hands-on experience with:

• PLC programming & troubleshooting

• Industrial cameras, lenses, and lighting

• Vision-based inspection systems

• Industrial printers (TIJ/CIJ/laser)

• Track & Trace systems

• Automation tools & interfaces

• Good knowledge of MySQL / MS SQL

• Familiarity with JIRA, Confluence

• Basic to intermediate Python skills

• OS installation, drivers, and system configuration

• Experience with automation/testing tools

Soft Skills

• Strong analytical and problem-solving skills
• Effective communication and customer handling
• Ability to work independently during site visits
• Strong documentation discipline and process orientation

Education & Experience

• Bachelors degree in Electronics, Electrical, Instrumentation, Mechatronics, Computer Science, or related field
• 5- 10+ years of experience in inspection systems, industrial automation, or related domain