QA Executive (Quality Assurance Executive)

Candidates who belongs to Medical Device and interested for Job can directly reach out on 7984420926 or on amisha.parmar@miraclus.com for more discussion

Role & responsibilities

1.1 Control documents, data and records of company pertaining to purchase, outsourced activities, Manufacturing & process, sales, quality control, dispatch, post market surveillance and vigilance.

1.2 Demonstrate compliance during an audit (regional/national/international) related to quality and product approvals.

1.3 Establish, maintain and update master lists such as master list of documents, records, Obsolete list, Revision history and distribution retrieval list, machines list, Instrument and equipments list etc.

1.4 Identification, filling, storage and maintenance of documents and QA related records.

1.5 Ensure all the records are filled in timely manner.

1.6 Review batch manufacturing and inspection records and release the batch.

1.7 Responsible for retaining at least one unit of sample from each batch manufactured.

1.8 Identify and implement CAPA for non-conformance observed during any stage of lifecycle of medical device, in internal/external audits or as a product complaint.

1.9 Responsible for Design Develop verification and validation protocols along with Design and Development department.

1.10 Training and ensuring all assigned employees are aware of and comply with company policies, quality procedures, and related standard requirement.

1.11 Releasing final product and disposition of Non-conforming material.

1.12 Review product traceability and finished goods release processes.

1.13 Establishing and maintaining programs, procedures and controls ensuring that product and raw materials are manufactured and controlled as per established procedures, specifications, Medical Device regulations and ISO standards.

1.14 Support projects and new product introductions by establishing key checkpoints for new products and processes.

1.15 Maintain product traceability and finished goods release processes.

1.16 In-charge of maintaining all the records, site master file, technical construction files, design history file, device master file, design history records in accordance with related standard.

1.17 Responsible to review each department documentation as per defined timeline to check compliance with the standard requirement.

1.18 Responsible for order review.

1.19Authorize to review any internal process and documentation.

1.20 Authorize to change and implement quality management system according to the standard requirements.

1.21Authorize to take necessary actions to eliminate Non-conformance of product at any stage.

1. 22Authorize for batch release.

Perks and benefits

Company provide bus facility from (Narol) Ahmedabad to Kheda location.

Canteen facility available