Principal Software & Hardware Assurance Practitioner
Role details
Job location
Tech stack
Job description
About The RoleAs part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards., 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 communication.
Conduct Technical File reviews specific for products being authorized.
Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business.
Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager.
If required, undertake reviews of files and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements.
Key Accountabilities: Auditor
Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate, and to draw up records and reports on the corresponding audits.
Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business.
Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager.
If required, undertake reviews of files and make certification recommendations 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., A leading assurance and risk management company in Greater London is seeking experienced In-Vitro Diagnostic Medical Device Assessors and Auditors. The role involves planning and conducting medical device audits to ensure compliance with industry standards. Candidates..., What you'll be doing as a Functional Assessor: PIP Clinical Auditor Work closely with the Service Delivery Manager and Clinical Support Leads to provide quality assurance via internal audit to the new and experienced Functional Assessors.Developing a close relationship..., A leading cyber security consultancy in the United Kingdom is seeking a full-time Information Security Auditor / Assessor. In this customer-facing role, you will conduct cyber security audits including IASME Cyber Essentials and ISO27001 assessments. The ideal candidate..., The Federal Staff Consultant will be responsible for conducting FISMA and FedRAMP assessments. As a Federal Staff Consultant, you will have the opportunity to complete our federal audit training program, which is our own proprietary course that will enable you to be on your..., Job TitleClinical Auditor, ADHD service SalaryUp to £68,000 per annum (HCAS inclusive) HoursFull time - 3 days/week for Auditing function, 2 days per week clinical Responsible toHead of Pharmacy and Clinical Services Key Relationships Head of Service Delivery ADHD..., Conduct audits and assessments in accordance with ISO13485, MDSAP, MDR based on the directive, regulation, harmonized standards and other applicable regulatory requirement following DNV's accredited certification program and procedure.Ensure independent and ethical of all...
Requirements
Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below.
In-Vitro Diagnostic Devices
Biology or Microbiology
Genetic testing
Oncology
Chemistry or Biochemistry
Human Physiology
Medical Technology or Biotechnology
Medicine, Veterinary Medicine
Biomedical science - e.g. haematology, virology, molecular diagnostics
Nursing
Pharmacy, Pharmacology, Toxicology
Physiology
Preferred Knowledge
An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques;
Work experience in positions with significant QA regulatory or management systems responsibility;
Experience with Harmonised medical device standards for In-Vitro diagnostic medical devices;
Experience with Risk Management EN ISO 14971;
Medical device experience from auditing/in-work;
Experience auditing against recognised standards;
Experience of working under own initiative and in planning and prioritising workloads;
Should have a flair for technical writing, essential for exhaustive report writing.
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., A global quality assurance firm seeks an experienced auditor in the United Kingdom to oversee the auditing of medical device manufacturing under ISO and IVDR standards. The ideal candidate will have a technical degree in a relevant medical field, along with a minimum of 4..., A leading certification body in the United Kingdom is seeking a qualified Lead Auditor to conduct audits and assessments for compliance with ISO13485 and related regulations. The role requires a relevant degree and a minimum of 4 years' experience in the medical devices...
Benefits & conditions
A competitive salary and benefits package
A stimulating and diverse work environment with opportunities for professional growth and development - learn from highly skilled colleagues and customers
A supportive and friendly team of experts and innovators
Social benefits as per DNV location (local conditions apply)
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., We exist to create positive change for people and the planet. Join us and make a difference too!Position: Product Certification AuditorLocation: United Kingdom - Field BasedSalary: Competitive basic salary based on experience plus Company Car & BonusJoin a..., Head of Health, Safety & Fire Management Salary: £65,000 to £75,000 plus bonus Location: Primarily on-site (Surrey/Hampshire) Contract: Permanent Any additional information you require for this job can be found in the below text Make sure to read thoroughly, then...
