Functional Responsibilities:

- To support and review quality system processes and serve to improve awareness and communication on quality initiatives to support assigned quality goals and priorities.
- Reports to HOD to create, update Quality System procedures/instructions
- Monitor and maintenance of existing processes.
- Assist in internal and external audits
- Assist in creating and maintaining internal audit schedules and records including tracking CAPA activities as required.
- Assist in and prepare for the execution of Notified Body audits and track progress of responses
- Assist in investigating quality issues and interact with cross-functional teams, regarding these.
- Review and investigate customer complaints, determine product failure root causes and evaluate risk of failures
- Ensure that the quality system is understood and applied throughout the organization on all levels by personnel concerned.
- Completion of QMS records as and when request is received; handling of change control management.
- Assist in maintenance of Device Master Records, technical files,



other customer documents and applicable test reports of product conformity according to MDD 93/42/EEC and amendments 2007 (be aware of the latest regulation such as MDR/745 2017) and 21 CFR 820.
- Assist with international product registrations, wherever QA support is required.

Competencies:

- Knowledge of quality systems (ISO 13485), associated documentation, EU MDR 745 and amendments 2007 and 21 CFR 820.
- Knowledge of medical device industry and medical device regulations including pertinent standards and guidance
- Bachelor’s / Master’s degree in a related field;
- Be aware of the latest medical device regulations
- Very proficient in attention to detail
- Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment
- Knowledge of Microsoft Office including Excel, with an ability to learn other computer based systems.
- Ability to work in collaborative and independent work situations
- Ability to remain calm and receptive in fast paced situations

Pay: ₹75,000.00 - ₹85,000.00 per month

Perks:

- Health insurance
- Leave encashment
- Paid time off
- Provident Fund

Work Location: In person

📌 Deputy Manager - Quality Assurance (India)
🏢 Medico Electrodes international
📍 India