Job Purpose:

All applicants must have experience in ISO 13485, EU medical device Regulations (MDR

745 and amendments 2007) and 21 CFR 820.

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

 Knowledge of medical device industry and medical device regulations including pertinent standards and guidance

 Bachelor’s degree in a related field ; preferably Masters

 Be aware of the latest medical device regulations

 Very proficient in attention to detail

 Ability to work and communicate with others in a qualified and effective manner, within a team-oriented environment

📌 Assistant Manager QA (Noida)
🏢 Nextgen Group
📍 Noida