Job Title: QA Engineer

Department: Quality Assurance

1.Job Purpose : This position will be reporting to Head of Quality and provide support for coordination on change control, Validation, Deviations, Customer complaints, Customer audits, ISO audit and its activities, CAPA, documentation, records updating and Technical Master File/Devices Master File, Master data maintenance & Train team. Overall responsible for coordination on calibration of tools and measuring devices.

2. Job Responsibilities/Objectives

2.1 Responsible to implement, monitor and maintain all QMS & ISO 9001, ISO 13485 and CE requirements.

2.2 Responsible to support Process and Equipment validation & its documentations.

2.3 Responsible to support and handle customer audits independently.

2.4 Responsible for Customer related activities-Handling of customer Questionnaire & its updating

2.5 Responsible for coordinate for calibration of tools & measuring devices at external source.

2.6 Responsible for coordination on change control, Validation, Deviations, Device Master File, Technical Master File,

Customer complaints, ISO audit and its activities and CAPA etc.,

2.7 Responsible for Preparation & up-gradation of SOP's.

2.8 Responsible for training and training record preparation.

2.9 Supervise, assess and monitor performance of subordinates, monitor training needs and provide training & counselling to subordinates where the need arises.

2.10 Responsible for conducting GMP training to all employees.

2.11 Responsible to prepare monthly QA & trend reports.

2.12 Responsible to liaise with Supplier on quality matters and non-conformance.

2.13 Any other duties as assigned by management.

2.14 Ensure that all the documentation is handled in accordance with GMP requirements.

2.15 Ensure that PO/PR are raised according to all applicable financial procedures/policies.

2.16 Simplify processes and improvements.

3. Job Responsibilities/Objectives- Microsoft Word, Excel and power point handling Knowledge in Documentation and GMP

4.Skills, Knowledge & Experience - Professional, Technical Graduate in science / Engineering with Minimum 3 years- of experience in QC and QA department - Knowledge in QA - Exposure in Audits and documentation - Knowledge in calibration activities - Good Written and verbal communication skill in English - Good interpersonal skills.

5. The candidate should have experience to work in QC on need basis.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.