Shira MedTech
Website:
shiramedtech.com
Job details:
Job Description – Quality Assurance Executive / Senior Executive
Department: Quality Assurance
Experience: 3–7 years in Medical Device
Employment Type: Full-time
Reporting To: CEO
Location: Gandhinagar, Gujarat
Job Summary
We are looking for a competent and self-driven Quality Assurance professional with 3–7 years of experience in medical device and sterilization, surgical instruments and higher risk devices. The candidate should be capable of handling internal and external audits, routine QA activities, quality documentation, compliance monitoring, and coordination with cross-functional departments. The candidate will also act as the Management Representative (MR) and coordinate QMS implementation, maintenance, performance reporting, management reviews, and continual-improvement activities.
Key Responsibilities
• Plan, conduct, and document internal quality audits.
• Coordinate and support customer, certification-body, supplier, and regulatory audits.
• Prepare audit schedules, checklists, reports, observations, and compliance records.
• Follow up on audit findings and ensure timely closure of corrective and preventive actions.
• Handle routine QA activities and ensure adherence to approved procedures.
• Manage deviations, non-conformances, CAPA, change controls, and related investigations.
• Perform root-cause analysis and recommend effective corrective and preventive measures.
• Prepare, review, revise, issue, and control SOPs, work instructions, formats, specifications, and quality records.
• Ensure effective document control, including version control, distribution, retrieval, archival, and disposal of obsolete documents.
• Monitor compliance with the Quality Management System and applicable statutory, regulatory, and customer requirements.
• Review batch, process, inspection, testing, or production records, as applicable.
• Coordinate with Production, Engineering, Purchase, Stores, QC, and other departments to resolve quality-related issues.
• Support supplier qualification, supplier audits, and supplier-performance monitoring.
• Handle customer complaints, coordinate investigations, and monitor closure of corrective actions.
• Conduct quality-awareness and SOP training for employees.
• Identify opportunities for continual improvement in systems, processes, and documentation.
• Maintain audit readiness and ensure that quality records are complete, accurate, traceable, and readily retrievable.
Required Qualifications
• Bachelor’s degree or diploma in Engineering, Science, Pharmacy, or another relevant discipline.
• 3–7 years of relevant experience in Quality Assurance, Exposure to Medical device and sterilization, surgical instruments and higher risk devices is preferred.
• Working knowledge of Quality Management Systems and applicable standards such as ISO 13485, GMP, or other relevant standards.
• Practical experience in audits, CAPA, root-cause analysis, deviation/non-conformance management, change control, and document control.
• Experience using quality tools such as 5 Why, Fishbone Diagram, Pareto Analysis, 8D, and risk assessment.
• Internal Auditor or Lead Auditor certification will be preferred.
Key Skills and Competencies
• Ability to manage audits and routine QA responsibilities.
• Strong analytical, investigation, and problem-solving skills.
• Good understanding of quality systems and compliance requirements.
• Strong documentation and report-writing ability.
• Effective communication and cross-functional coordination skills.
• Attention to detail and commitment to accuracy.
• Ability to prioritize multiple assignments and meet deadlines.
• Confident in communicating with auditors, customers, suppliers, and internal stakeholders.
• Proactive, disciplined, and improvement-oriented approach.
How to Apply:
Through LinkedIn or email your CV and Cover letter to careers@shiramedtech.com
Click on Apply to know more.