
(3 Days Left) Medical Devices-Assessor/ Auditor
14 hours ago
Job Description About Us We 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 insights so that critical decisions can be made with confidence. As a trusted voice for many of the world's most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. - Conduct audits (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 work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. - Complete specific projects in relation to medical device procedures, processes, systems and documentation. - If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. - Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you'll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: - work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. - work in the application of device technology and its use in health care services and with patients. - testing devices for compliance with the relevant national or international standards. - conducting performance testing, evaluation studies or clinical trials of devices. - 5 + years relevant professional experience in quality management is essential. In addition to the above you'll also need to demonstrate the following. - An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques - Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application - Knowledge of MDR 2017/745, MDSAP, IMDR - Work experience in positions with significant QA, Regulatory or management systems responsibility - Experience with Harmonized medical device standards and for active & non active devices. - Experience with Risk Management EN ISO 14971 - Experience auditing against recognized standards - Experience of working under own initiative and in planning and prioritizing workloads - Solid knowledge of non-active devices - Solid knowledge of sterilization processes The Following Attributes Are Essential - Work actively with a Team of Assessors/ Auditors. - Experience of reviewing audit packs - Review of technical documentation - Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer - Flexible work arrangements for better work-life balance - Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) - Medical benefits ( Insurance and Annual Health Check-up) - Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) - Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) - Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) - Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You - University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. - Qualified MDR Assessor from a reputed EU Notified Body, desirable. - Experience with scientific literature searches or peer review in the medical context. - Fluent in written and spoken English. - Experience working with Various Digital Tools. - Excellent organizational and professional communication skills. Security and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices.
-
Medical Assessor
4 days ago
Bengaluru, Delhi, Mumbai, NCR, India Sofomation Energy Full time ₹ 15,00,000 - ₹ 25,00,000 per yearOPENING FOR A WELL KNOWN OIL AND GAS COMPANY In MIDDLE EAST:Position: Medical Devices-Assessor/ AuditorExperience:Require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs.5 +...
-
Only 24h Left: Senior Device Engineer
2 weeks ago
India Sofomation Full timeJob Description OPENING FOR A WELL KNOWN OIL AND GAS COMPANY In MIDDLE EAST: Position: Medical Devices-Assessor/ Auditor Experience: - Require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management,...
-
Medical devices auditor(talent pipeline)
1 week ago
India BSI Full timeJob Description Great that you're thinking about a career with BSI! Position: Medical devices auditor Location: India(home based) What Duties You'll Perform - As a Regulatory Services business stream Client Manager(Auditor) you'll be responsible for frequently travelling and having overnight stays across the South Korea. You'll assess to ISO 13485...
-
▷ (Apply in 3 Minutes) Device Engineer
2 weeks ago
India Sofomation Full timeOPENING FOR A WELL KNOWN OIL AND GAS COMPANY In MIDDLE EAST: Position: IVDR Assessor Experience: - 4+ years of industry experience in IVD devices (design, testing, manufacturing, or regulatory). - Minimum 2 years in hands-on product work or as an assessor/auditor. Minimum Requirement: - Degree in a relevant field: Biology, Microbiology, Biochemistry,...
-
India Europe SGS Full timeCompany Description We are SGS - the world s leading testing inspection and certification company We are recognized as the global benchmark for sustainability quality and integrity Our 99 600 employees operate a network of 2 600 offices and laboratories working together to enable a better safer and more interconnected world At SGS we have an open...
-
Device Engineer
2 weeks ago
Delhi, India Sofomation Full timeOPENING FOR A WELL KNOWN OIL AND GAS COMPANY In MIDDLE EAST:Position: IVDR AssessorExperience:- 4+ years of industry experience in IVD devices (design, testing, manufacturing, or regulatory).- Minimum 2 years in hands-on product work or as an assessor/auditor.Minimum Requirement:- Degree in a relevant field: Biology, Microbiology, Biochemistry,...
-
Device Engineer
2 weeks ago
India Sofomation Full timeOPENING FOR A WELL KNOWN OIL AND GAS COMPANY In MIDDLE EAST:Position: IVDR AssessorExperience: 4+ years of industry experience in IVD devices (design, testing, manufacturing, or regulatory).Minimum 2 years in hands-on product work or as an assessor/auditor.Minimum Requirement:Degree in a relevant field: Biology, Microbiology, Biochemistry, Biotechnology,...
-
Device Engineer
2 weeks ago
India Sofomation Full timeOPENING FOR A WELL KNOWN OIL AND GAS COMPANY In MIDDLE EAST: Position: IVDR Assessor Experience: 4+ years of industry experience in IVD devices (design, testing, manufacturing, or regulatory). Minimum 2 years in hands-on product work or as an assessor/auditor. Minimum Requirement: Degree in a relevant field: Biology, Microbiology, Biochemistry,...
-
Auditor (Non-active Medical Devices)
2 days ago
India TÜV SÜD South Asia Pvt Ltd Full timePerforms assigned onsite audits at Medical Device Manufacturer’s Premises (Min.50% travel). - Auditing Quality Management Systems of Medical Devices in accordance with the requirements of the EU Medical Device Regulations 2017/745, and other QMS certification schemes such as EN ISO 13485, MDSAP, ISO 15378, ICMED 13485 and ISO 9001. - Prepare pre-audit...
-
Project Manager
14 hours ago
Pune, India Infosys Limited Full timeJob Description Job Description: - Bachelor s degree required preferably in Engineering or Project Management - 10 years of hands on experience in leading medical devices products development maintenance - 5 years of relevant experience in project management - PMP certification - Candidate to be comfortable in front of all levels of the organization as well...