Deputy Manager - Quality Assurance

Job Purpose:

To ensure product and process quality by implementing quality systems, monitoring compliance, managing CAPA, and driving continuous improvement to meet customer and regulatory requirements.

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
• Bachelors / Masters 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