Supplier Quality Engineer - Medical Devices

Job Description

Cyient is a global engineering and technology solutions company. As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ahead of the curve. We leverage digital technologies, advanced analytics capabilities, and our domain knowledge and technical expertise, to solve complex business problems.With over 15,000 employees globally, we partner with clients to operate as part of their extended team in ways that best suit their organization s culture and requirements. Our industry focus includes aerospace and defence, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy.Job Description
• Review new and modified product design documentation for quality characteristics,including manufacturability, serviceability, testability, reliability, and product requirements.
• Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations.
• Knowledge on EU MDR requirements and strong at gap analysis and remediation.
• Hands on experience in standards testing and working with notified bodies on external testing.
• Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
• Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
• Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Participate and provide input to training on department / division procedures and policies.
• Participate when appropriate in internal audits
• Medical Devices experience.Minimum Qualification
• B E or B.Tech
• Minimum 2-3 years of quality engineering experience or equivalence and overall 2-5 years of experienceKey Technical Competencies
• Previous experience working in a cross-functional team environment.
• Familiar with statistical software tools (Minitab, Stat Graphics)
• Familiar with ISO 13485, IEC 60601and product specific industry standards.
• Hands-on experience on EU MDR remediation.
• Computer literate and experience with PCs, networks, and applicationssome travel required
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
• Good verbal and written communication skills including protocol / report development andtechnical presentations.
• Risk Management, ISO 14971
• Review new and modified product design documentation for quality characteristics,including manufacturability, serviceability, testability, reliability, and product requirements.
• Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations.
• Knowledge on EU MDR requirements and strong at gap analysis and remediation.
• Hands on experience in standards testing and working with notified bodies on external testing.
• Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
• Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
• Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Participate and provide input to training on department / division procedures and policies.
• Participate when appropriate in internal audits
• Medical Devices experience.Minimum Qualification
• B E or B.Tech
• Minimum 2-3 years of quality engineering experience or equivalence and overall 2-5 years of experienceKey Technical Competencies
• Previous experience working in a cross-functional team environment.
• Familiar with statistical software tools (Minitab, Stat Graphics)
• Familiar with ISO 13485, IEC 60601and product specific industry standards.
• Hands-on experience on EU MDR remediation.
• Computer literate and experience with PCs, networks, and applicationssome travel required
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
• Good verbal and written communication skills including protocol / report development andtechnical presentations.
• Risk Management, ISO 14971
Skills & ExperienceISO 13485:2003- Quality in Medical Devices, Quality Assurance, Quality assurance in Software and manufacturing, Quality Control, Quality Engineering Certification, Supplier QualityCyient is an Equal Opportunity Employer.Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter.,

Keyskills :
product designquality controlgap analysisinspectioncontinuous improvement facilitationspcqualityppap