
Required Quality Assurance(QA) professional from medical devices Ind
3 weeks ago
JOB RESPONSIBILITIES
Overall responsibility of continual improvement and implementation of the organization's Quality Management System
Overall responsibility for facing 3rd-party regulatory audits, including CE audits (as per EUMDR), ISO 13485 audits, USFDA inspections, customer audits, etc.
To work as PRRC (Person responsible for regulatory compliance as per EUMDR.
Leading proper conduct and closure of Internal Quality Audits
Management of customer complaints & CAPA.
Management of Product-related documentation including Risk Management files, Pre-clinical Test reports, Clinical Evaluation reports, Usability Engineering files
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, Gurugram, NCR, India Harsoria Healthcare Full time ₹ 20,00,000 - ₹ 25,00,000 per yearJOB RESPONSIBILITIESOverall responsibility of continual improvement and implementation of the organization's Quality Management SystemOverall responsibility for facing 3rd-party regulatory audits, including CE audits (as per EUMDR), ISO 13485 audits, USFDA inspections, customer audits, etc.To work as PRRC (Person responsible for regulatory compliance as per...
-
QA Executive(Medical Devices)
7 days ago
Delhi, Delhi, India Sai Placement Full timeFrom 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 ...
-
Quality Assurance Executive
5 days ago
Okhla, Delhi, Delhi, India St. Stone Medical Devices Privted Limited Full timeJob 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...
-
Quality Assurance Manager
1 week ago
Gurgaon, Haryana, India Genes2me Full time ₹ 15,00,000 - ₹ 25,00,000 per yearRole & responsibilitiesWe are looking for a highly skilled QA professional with expertise in IVD medical devices. The role requiresstrong knowledge of international regulatory compliance, audits, product registration, and documentation,ensuring that our products meet the highest standards of quality and safetyPreferred candidate profileLead and manage audits...
-
Quality Engineer
3 days ago
Gurgaon, Haryana, India Infosys Full timeResponsibilities o 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...
-
Quality Assurance Tester
7 days ago
New Delhi, India Euronoxx Reserves ltd Full timeLocation: Hybrid (Home-Based and Office - India) Pay: Negotiable per year Vacation: Paid time off Schedule: Mondays to Saturdays Experience: Quality Assurance 1+ years (required)We are looking for a Quality Assurance (QA) Tester to assess software quality through manual and automated testing. You will be responsible for finding and reporting bugs and...
-
In-vitro Diagnostic Medical Device Assessors
3 days ago
Delhi, India DNV Full timeLocal 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...
-
Medical Device Engineer
3 weeks ago
Delhi, India Ellaya Health Full timeCompany Description We are an innovative Indian med-device company driven by the vision of creating novel solutions that improve lives. By harnessing cutting-edge engineering and deep clinical understanding, we are building a new generation of medical devices designed to address critical, underserved needs in healthcare. Our first product embodies this...
-
Hiring Territory Sales Head Grasim Inds. Ltd
3 weeks ago
DoubleTree by Hilton Hotel Gurgaon - New Delhi NCR, India Century Rayon (under The Management Operation Of Grasim Industries Ltd.) Full timeHiring Territory Sales Professional for VFY Business Grasim Inds. Ltd. Job profile: To lead and drive sales operations for the North India region, focusing on textiles (yarn, fabric, garments, or related products). The role involves achieving sales targets, expanding market presence, building strong customer relationships, and identifying growth...
-
Medical Device Regulatory Lead
4 days ago
New Delhi, India ArtiXio Full timeAbout the RoleWe are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO, and other global...