Electronics - Hardware - Testing Engineer / QA - QMS Engineer

Job Summary:

We're looking for a highly skilled electronic testing & QA / QMS Engineer to test, develop, implement, and maintain our quality management system, focusing on medical device and other standards and regulations.

Key Responsibilities:

1. Testing of electronic controllers - visual-in process-live and final product testing

2. Shall be responsible for complete QA function, right from inward component inspection up to final product quality assurance. Generate reports, analysis, and meeting quality objectives as per plan.

3. Develop, implement, and maintain QMS processes and procedures.

4. Conduct internal audits and manage corrective actions.

5. Ensure compliance with:

- ISO 13485 (Medical Devices)

- ISO 14971 (Risk Management)

- CDSCO (Central Drugs Standard Control Organization) regulations

- MDR (Medical Device Rules), India

- ISO 9001

4. Collaborate with cross-functional teams to identify and mitigate quality risks.

5. Analyse quality data and recommend process improvements.

6. Develop and deliver training programs for employees.

7. Manage documentation and records.

8. Interface with external auditors and regulatory bodies.

Health and Safety Responsibilities:

1. Ensure compliance with occupational health and safety regulations (Factories Act, 1948).

2. Develop and maintain workplace safety policies and procedures.

3. Conduct risk assessments and implement controls.

4. Investigate incidents and near-misses.

Requirements:

1. Bachelor's degree/Diploma in Engineering -Electronics.

2. 3+ years of experience in QMS, preferably in medical devices.

3. Certification in ISO9001:2015, ISO 13485, ISO 14971, or similar standards.

4. Excellent knowledge of quality tools (5S, Six Sigma, Lean, etc.).

5. Strong analytical, problem-solving, and communication skills.

6. Ability to work independently and collaboratively.

Desirable Skills:

1. Experience with medical device development.

2. Familiarity with Indian regulatory requirements (CDSCO, MDR).

3. Knowledge of quality management software (e.g., QMS, EQMS).

4. Certification in Lean Six Sigma (Black Belt/Green Belt).

5. Knowledge of risk management standards (e.g., ISO 14971).

What We Offer:

1. Competitive salary and benefits package.

2. Opportunity to work on cutting-edge medical device projects.

3. Professional growth and development opportunities.

4. Collaborative and dynamic work environment.