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| Job Location | Delhi |
| Education | Not Mentioned |
| Salary | Rs 6 - 9 Lakh/Yr |
| Industry | IT - Software |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Designation: Quality Manager Reports to: DirectorIndustry: Medical Devices (Class II & Class III Orthopedic Implants)Place of Posting: Sonepat 2 KM from Delhi BorderPick & Drop available from Rohini & Pitampura (Upon normalcy after Covid-19) Working Hours: 9:30 AM to 6:00 PM (Monday to Saturday)Job Responsibilities & DutiesPlan, establish and maintain a quality management system in accordance with ENISO 13485:2016 & MDSAP.Develop standardized production, quality, and customer-service standards.Identify potential risks before they become a problem, focusing on root cause analysis and preventive actionIdentify and implement CAPA for non-conformance observed during any stage of the lifecycle of medical device, in internal/external audits or as a product complaint.Ensuring all established quality and delivery commitments are met such as working within FDA regulations, Design Control and ISO Standards.Training and ensuring all assigned employees are aware of and comply with company policies, government procedures, and regulations.Working closely with product development and product transfer teams.Releasing final product and disposition of Non-conforming material.Maintain product traceability and finished goods release processes.Support projects and new product introductions by establishing key checkpoints for new products and processes.Supplier audit and Qualification.Responsible for all clean room, and packing activity as per the QMS requirement.Build a strong team through coaching, mentoring, specific training and performance evaluationsOther duties as assigned.Key Skills:USFDA, Quality Assurance, Medical Devices, QMS, USFDA, MDSAP, ISO 13485, Orthopaedic, Mechanical Engineer.Required Candidate profileDesired Education, Experience, Skills & Competencies:Bachelors/Master s degree in Mechanical Engineering10+ years relevant work experience from Medical Devices Industry preferably (Class II & Class III Orthopaedic Implants).Must have ISO 13485:2016 internal Auditor certificateSuperb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).Excellent computer and internet search skills.Strong ability to multi-task and to meet business deadlines.Excellent organizational skills with an ability to think proactively and prioritize work.Key Skills:USFDA, Quality Assurance, Medical Devices, QMS, USFDA, MDSAP, ISO 13485, Orthopaedic, Mechanical Engineer. ,
Keyskills :
quality controlroot causeinspectionproduct developmentmedical devicesquality assuranceisoquality managementdocumentationsupplier auditproduct transferinternal auditroot cause analysisiso 13485qualityfinished goodsdesign controlmanagement