Quality Assurance Specialist

Advanced Medical Solutions; Gurugram District; On-site; INR 600,000 - 900,000; Full time

Job summary

Advanced Medical Solutions is seeking an Executive – Quality Assurance to oversee document control, QA procedures, SOPs, and change control within a medical devices quality system.

The role includes preparing and reviewing DHF, CER, PMS, PSUR, and PMCF reports, conducting internal audits, and supporting external audits. Training and data analysis are also key responsibilities, ensuring compliant batch release and continuous improvement.

Qualifications

• Technical files per EUMDR requirements.
• Prepare technical files per MDD for class I, IIa, IIb and III medical devices.
• Prepare and review Design History File (DHF), CER, PMS, PSUR, PMCF reports.

Responsibilities

• Management and control of documents, QA procedures & SOPs.
• Review and issue of work instructions, SOPs, QSPs & artwork.
• Prepare and analyze quality trends.
• Handle change control and non-conformity of product.
• Conduct internal and supplier quality audits; support external audits.
• Review corrective actions and preventive actions and monitor effectiveness.
• Coordinate calibrations and review proof checks and batch records.
• Provide GMP, QSPs, SOPs training and update work instructions.
• Assist in investigations of non-conformities and market complaints.
• Compile data for management reviews and data analysis.
• Review quality test reports and printing specifications.
• Support microbiological procedures and GLP training.
• Oversee batch release review and release.

Skills

EUMDR tech files

MDD compliance

Regulatory docs prep

Job description

About the Role

Executive – Quality Assurance

Responsibilities

• Management and control of document, Quality assurance procedure & SOPs.
• Control, Review and issuance of work instructions, SOPs, QSPs & artwork etc.
• Preparation and review of procedure, QSPs, qualification and validation protocol.
• Preparation and analysis of quality trends.
• Handling of change control management system and non-conformity of product.
• Conduct internal audit, supplier quality audit and support in external audit.
• Review of correction, corrective action and preventive action including effectiveness monitoring.
• Review and follow-up with internal department for external and internal calibrations as per schedule.
• Review/approve of proof check, print proof and artwork.
• Review the batch manufacturing Record.
• Provide training related to GMPs, QSPs, SOPs etc.
• Communicate and update the work instructions.
• Support in the investigation of non-conformity and market complaint.
• Collect the data for management review meeting & data analysis.
• Review of all quality test reports, printing specification and trends.
• Provide training to Microbiological procedure, GLP, QSPs, SOPs, GMP etc.
• Responsibility to review and release of batch release.

Required Skills

• Technical files as per the requirement of EUMDR
• Preparing Technical files as per the requirement of MDD and ensure the compliance with the MDD requirements for class I, IIa, IIb and class III medical devices
• Preparation and review of Design History File, Clinical Evaluation Report, PMS Report, PSUR, PMCF report etc.

Pay range and compensation package

Full time

Equal Opportunity Statement

We are committed to diversity and inclusivity.