Required Quality Assurance(QA) professional from medical devices Ind

2 weeks ago


Delhi Gurugram NCR, India Harsoria Healthcare Full time ₹ 15,00,000 - ₹ 25,00,000 per year

JOB RESPONSIBILITIES

  1. Overall responsibility of continual improvement and implementation of the organization's Quality Management System

  2. Overall responsibility for facing 3rd-party regulatory audits, including CE audits (as per EUMDR), ISO 13485 audits, USFDA inspections, customer audits, etc.

  3. To work as PRRC (Person responsible for regulatory compliance as per EUMDR.

  4. Leading proper conduct and closure of Internal Quality Audits

  5. Management of customer complaints & CAPA.

  6. Management of Product-related documentation including Risk Management files, Pre-clinical Test reports, Clinical Evaluation reports, Usability Engineering files

  7. Conducting required validations, in particular Sterilization Validation, Packaging Validation, Shelf-Life Studies/Stability Studies, Transportation Validation, etc.

Preferred Candidate Profile

ISO 13485 lead auditor training

Location - Gurgaon (HR) & Baddi (HP)

AT LEAST 8 years experience in CE-Certified disposable medical device company

depth knowledge of ISO 13485 audits, EUMDR, USFDA inspections, customer audits.



  • Delhi, Delhi NCR, India beBeeCompliance Full time ₹ 9,00,000 - ₹ 12,00,000

    Medical Devices ProfessionalWe are seeking a highly skilled Medical Devices Professional to join our team. The ideal candidate will have expertise in conducting audits and ensuring compliance with regulatory standards.Plan, conduct, and report on audits of medical devices to ensure compliance with ISO 13485, EU MDR, and MDSAP standards.Review and evaluate...


  • Delhi, Delhi, India Sai Placement Full time

    From 1 to 6 year(s) of experience- ₹ Not Disclosed by Recruiter- Ahmedabad, Delhi / NCR, Vadodara**Roles and Responsibilities** Person knowledge about Compliant handling, Risk Management, Drafting, ( D & D Documents), QMS, Export / Registration Must Have Knowledge about Medical Device Industry **Perks and Benefits** Key Skills QAQMSRisk Management ...


  • Delhi NCR, Delhi, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 28,00,000

    Job Title: Medical Devices SpecialistWe are seeking a skilled Medical Devices Specialist to join our team. As a key member of our audit team, you will play a vital role in ensuring the quality and compliance of medical devices.About the Role:Plan and conduct audits in accordance with ISO 13485, EU MDR, and MDSAP standards to ensure compliance and adherence...


  • Okhla, Delhi, Delhi, India St. Stone Medical Devices Privted Limited Full time

    Job Title: QA Executive Company: St.Stone Medical Devices Private Limited Budget: 25k-35k (In-hand)/month **Job Type**: Full-Time Schedule: Day Shift Timing: 10:00 am to 6:00 pm Location: A80 DDA SHED, Okhla Phase II, Delhi Experience: 1-3 years **Responsibilities**: Ensure products adhere to legal and safety standards. Design product and testing...

  • Qc Microbiologist

    4 days ago


    Delhi, Delhi, India Devine Meditech Full time

    **Job Summary**: The **QC Microbiologist** plays a crucial role in ensuring the sterility, cleanliness, and microbiological quality of **Intraocular Lenses (IOLs)** and other medical devices. This role involves conducting microbiological testing, environmental monitoring, and compliance verification per regulatory standards such as **ISO 13485, ISO 14971,...


  • Delhi, Delhi, India Lifelancer Full time

    Job Title Medical Devices-Assessor AuditorJob Location Delhi IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level About UsWe are the independent expert in assurance and risk management Driven by our purpose to safeguard life property and the environment we empower our customers and their stakeholders with facts and reliable...


  • Delhi, India DNV Full time

    Local Unit & Position Description: Key Accountabilities - Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. - Conduct Technical File reviews specific for products being authorized. - Complete all chargeable...


  • Delhi, Delhi, India beBeeClinical Full time ₹ 9,00,000 - ₹ 15,00,000

    Clinical Application SpecialistConduct in-depth training sessions for healthcare professionals on medical devices and software applications, providing tailored insights to enhance user experience.The ideal candidate will deliver comprehensive training materials, including interactive presentations and user guides, to ensure seamless integration of medical...


  • Delhi, Delhi, India beBeeRegulatory Full time ₹ 17,50,000 - ₹ 22,50,000

    Senior Quality Assurance ManagerJob Overview:We are seeking a seasoned professional to oversee supplier quality assurance, development, and compliance in regulated industries. The role involves leading audits, driving quality improvement initiatives, and building strong supplier partnerships.Key Responsibilities:Develop and implement supplier quality...


  • Delhi, Delhi, India beBeeMechanical Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Job Title: Mechanical Design Architect">You're a visionary Design Engineer driven by the passion to enhance patients' lives through groundbreaking medical devices. At our organization, your passion finds its purpose. Join us to design, develop, and test advanced mechanical systems for next-generation medical devices, working closely with a leadership team...