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Quality Assurance Engineer- Medical Devices

4.00 to 6.00 Years   Hyderabad   14 Nov, 2021
Cyient Limited
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

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 DescriptionQuality Assurance -MT&H:

  • Provide guidance for product development under Design Controls: User and Product requirements, Functional Specifications, Design Verification, Design Validation, Test Method Validation, Risk Management, and Design Reviews.
  • Provide guidance and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulatory and international standards
  • Work closely with New Product Introduction teams to meet compliance requirements on schedule
  • Participate on team projects and assignments, facilitating or leading sub-teams as necessary.
  • The Staff Design Compliance Engineer will be responsible for supporting New Product Introduction (NPI) programs by providing input to the development teams and authoring or approving Design Controls deliverables.
  • This Design Assurance position is also responsible for providing guidance and coaching for post-market product sustaining activities, such as design changes and CAPAs.
  • Review and Assess component Supplier Processes, Supplier audits, Identify Quality Issues, Maintain Documentation and Reports
Education:
  • Bachelor s degree in Engineering discipline required.
Experience:
  • New Product Development (NPD) or New Product Introduction (NPI) experience working in Manufacturing Engineering, Design Engineering, Design Compliance, Quality, or Regulatory role;
  • 4 years of progressive professional experience is preferred.
  • Experience in Engineering, Quality, or Regulatory in a regulated medical device manufacturing environment.
  • Experience with refrigeration systems is a plus.
  • Six Sigma, Shainin, or other statistical training/certification is a plus.
Knowledge, Skills, Abilities:
  • Strong knowledge of Design Controls, Risk Management, and regulatory guidelines and their application.
  • Excellent interpersonal and communication skills with the ability to effectively interface with technical personnel at various levels of the organization.
  • Ability to act quickly and decisively.
  • Review and Assess Supplier Processes, Supplier audits, Identify Quality Issues, Maintain Documentation and Reports
  • Excellent analytical abilities
  • Working experience with Global team
  • Excellent communication skills.
  • Willing to travel based on need.
Skills & ExperienceMedical Device Product Development Experience, Regulatory Experience, 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 :
design assurancedesign engineeringdesign validationcontinuous improvement facilitationsupplier qualitynew product introductionadvanced analyticssupplier auditsmethod validationrisk managementglobal engineering

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