Quality Assurance Engineer

5 days ago

india Sol-Millennium Medical Group Full time

Purpose of the positionThe Quality Assurance Engineer (QA Engineer) provides hands-on support of the Company's Quality Management System, in particular the complaint and CAPA management in our overall efforts to improve on our quality management system, be a strong advocate for our customers to resolve quality issues and achieve pre-market approvals. The QA Engineer Engineer’s primary responsibilities include assuring the full implementation of the complaint handling/vigilance system, compliance to international regulatory requirements, the implementation and maintenance of an effective communication with customers, support product distribution. The QA Engineer will also assure the maintenance of quality and regulatory documentation.Responsibilities & duties:Regulatory ComplianceEnsures regulatory compliance to applicable the relevant international country-specific requirements and policies.Maintains a state of compliance control for ISO13485, MDSAP, EU Medical Device Directives, EU Medical Device Regulations and Quality System RequirementsEnsures implementation of new and changing regulationsProvides documentation in support of regulatory submissions and customer requestsSupports implementation and execution of the regulatory compliance requirementsComplaints, CAPAs and NCRsTimely reporting the complaints into the document control platform (e.g. Greenlight Guru)Supports the complaint evaluation and investigation, including failure analysis.Reviews quality and manufacturing records, including DHRs, NCs, CAPAs, complaint records, failure analysis data and reports, and risk documentation.Supports trending and risk analysis; evaluate risk to patient.Assists or leads in the identification and activities of CAPAs and NCRsMaintains all relevant complaint handling and vigilance documents in a compliant mannerSubmit reportable events to regulatory agencies/ customersCommunicates effectively and in a timely manner to customersQuality AssuranceEnsure compliance with ISO 13485, MDD/ MDR and other applicable regulations and standardsEstablish, follow, and maintain Quality Management System procedures, work instructions, and other processesParticipate in the authorities’ inspections, ISO certification and surveillance audits and other auditsSupplier Quality AssuranceInteract and coordinate activities with other departments, external vendors, and customersSupport the suppliers/ vendors onboarding and sourcing processSupport and verifies the execution of the suppliers’ CAPAInternal and external auditsSupport internal, external, and customer audits of the SQA programPerform quality reviews, audits, investigations, and CAPAsIdentify areas of improvement and implement plans to correct and prevent problems.LeadershipIntegrate knowledge of the Quality Policy and Corporate Objectives into work practices to support the businessWork cross-functionally with Commercial, Sourcing, SQA, RA, R&D to assure high quality complaint investigationsLead the QA projects and promote the Quality and Regulatory Culture through the companyAcademic & Formal QualificationsA diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devicesor four years of professional experience in regulatory affairs or in quality management systems relating to medical devicesknowledge of the medical devices EU regulationsknowledge of the ISO 13485 or ISO 9001 standardsASQ certification (Certified Quality Quality Engineer, Certified Quality Auditor, Certified Quality, Engineer)Work Experience & SkillsExperience in Quality Assurance for medical devicesGood working knowledge of the Microsoft OfficeWriting and approving standard operating procedures and work instructionsExperience in auditingExperience in the manufacturing and design of medical devicesExperience in the quality control and quality assurance of medical devices/ PPEproducts/ Biocides/ Cosmetics or Veterinary products

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