Design Quality Assurance

1 day ago

Pune, Maharashtra, India Infosys Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Design Quality Assurance - Medical

"QMS Knowledge of Regulatory standards CFR820 , ISO 13485 & 14971, 60601 Hands on experience on Risk Management. Good understanding of Post Market Survey and complaint handling. Design plan Medical Process DQC Deviation and CAPA preferred." "
• Be a part of core project team and support the quality engineering across the entire development cycle
• Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects.
• Lead the development and implementation of design verification and validation plans with project design lead.
• Lead the development of Critical to Quality (CTQs), design input and output documents.
• Lead the fixture qualification and test method validation.
• Participate and implement tools like Design of Experiments (DOE's), FMEA sessions, Risk Management and ensure compliance to CTQ's and safety requirements.
• Manage electronic document control and version control on all project related documents.
• Ensure adherence to the quality systems and design assurance SOPs.
• Lead usability, reliability, testing, verification and validation testing – internal and local vendors.
• Provide statistical testing and reliability plans.
• Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
• Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable).
• Co-Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why's analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
• Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed quality."

  • Design Quality Assurance

    1 day ago

    Pune, Maharashtra, India Infosys Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Job Description:BE BTech Mechanical OnlyExperience in medical device onlyProfessional training and certification in in Quality Management Systems including ISO 13485 Risk management ISO 14971 design assurance control verification and validationSound understanding of medical device regulatory requirements for Class II and III medical devicesProject planning...

  • Design Quality Assurance

    1 week ago

    Pune, Maharashtra, India Infosys Full time US$ 80,000 - US$ 1,20,000 per year

    Role & responsibilities:• Be a part of core project team and support the quality engineering across the entire development cycleLead product risk management, usability, reliability and design validation efforts for new product development and design change projects.Lead the development and implementation of design verification and validation plans with...

  • Design Quality Assurance

    2 weeks ago

    Pune, Maharashtra, India Capgemini Engineering Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Position:- Design Quality AssuranceDomain :- Medical (Mandatory)Location :- PuneExperience – 4-6 yrs Notice Period :- May Joiners (ONLY)DQA Keywords: Medical Device, QMS, Quality Management Systems ,ISO 13485, Risk management, Hazard Analysis.CAPA, PSURKey Responsibilities:-Be a part of core project team and support the quality engineering across the...

  • Quality Assurance

    2 weeks ago

    Pune, Maharashtra, India Inducare Pharma Private Limited Full time ₹ 4,80,000 - ₹ 7,20,000 per year

    Designation - Quality Assurance (QA)Industry - PharmaceuticalExperience YearsRoles And Resposibilities-•B.Sc. in Science, with analytical chemistry•Background in manufacturing and analytical techniques•5 + years relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance/Quality Control and/or Regulatory...

  • Quality Assurance

    1 week ago

    Pune, Maharashtra, India Aecom Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Work with Us. Change the World.  At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's most complex...

  • Quality Assurance

    7 days ago

    Pune, Maharashtra, India Trident International P Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

     Job Title: Quality Assurance & Technology ManagerLocation: Pune/JejuriJob Type: Full-timeReports To: GM Operations Role Overview:We're looking for a highly skilled and experienced Quality Assurance (QA) & Technology Manager to join our team at a leading solid tyre factory. You'll be a key player in ensuring our products meet the highest standards of...

  • Quality Control Engineer

    2 weeks ago

    Pune, Maharashtra, India Shree Quality Services Full time ₹ 2,50,000 - ₹ 7,50,000 per year

    Company DescriptionShree Quality Services is committed to being a trusted partner for businesses aiming to achieve the highest standards of quality, efficiency, and compliance. With extensive experience, we offer a wide array of services to support diverse industries in maintaining operational integrity, reducing risks, and improving performance. Our mission...

  • Quality Assurance Engineer

    1 day ago

    Pune, Maharashtra, India Raj Deep ENVIROCON LLP Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Company DescriptionRaj Deep ENVIROCON LLP specializes in providing turnkey solutions and manufacturing within the fields of Pneumatic Conveying Systems, Dust Collection systems, Grain handling systems, Air pollution control systems, and Bulk solids handling systems. We have expertise in designing and manufacturing associated equipment like Bag filters, Dust...

  • Quality Assurance Specialist

    7 days ago

    Pune, Maharashtra, India Hyper Lychee Labs Full time ₹ 1,50,000 - ₹ 28,00,000 per year

    KEY RESPONSIBILITES:We're seeking an experienced Quality Assurance Specialist with an unwavering commitment to meticulous quality standards. The ideal candidate is an exceptionally organized, methodical professional with the experience necessary to take our deliverables to the next level with respect to accuracy and customer centricity. You will be charged...

  • Quality Assurance Engineer

    1 week ago

    Pune, Maharashtra, India Neksoft Consultancy Services Full time US$ 90,000 - US$ 1,20,000 per year

    WE'RE HIRING | QUALITY ASSURANCE ENGINEER | 5+ years Experience Location: Head Office, Pune (Factory Site) Work Type: Onsite | Full-Time Only Local Pune Candidates Will Be Considered JOB SUMMARY We're looking for an experienced Quality Assurance Engineer to monitor, evaluate, and improve manufacturing processes related to boom pump production. This role...