Medical Device Auditor jobs
- AtkinsRéalisPotters Bar
- The Quality Auditor drives the development and implementation of quality systems and process improvements to ensure compliance with standards and reduce…
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View similar jobs with this employerMedical Device Regulatory and Quality Consultant
Often replies in 1 dayPA ConsultingMelbourn- Annual leave
- Company pension
- Private medical insurance
- Cycle to work scheme
- This role focuses on advising clients on the regulatory, Quality and compliance aspects of medical devices, through a strong understanding of regulatory and…
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- ICON PlcReading
- Employee assistance programme
- Company pension
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
- As a Principal Auditor CRQA at ICON, you will play a pivotal…
- ReckittNottingham NG1 1DQ
- Life insurance
- Employee assistance programme
- Trained and experienced lead auditor.
- Maintaining auditor qualification and competency to the required levels.
- Support delivery of team KPIs.
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- NovartisLondon
- Design and deliver global regulatory strategies for precision diagnostics, including companion diagnostics and in vitro devices.
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- DeloitteBelfast
- Company pension
- Health & wellbeing programme
- This role is key to managing and delivering end-to-end internal audit and controls assurance engagements that enhance clients’ control environments and…
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- Zimmer BiometRemote
- Health & wellbeing programme
- In collaboration with Chief Audit Executive responsible for managing all internal audit activities Responsibilities include conducting annual risk analysis,…
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- Zimmer BiometRemote
- Health & wellbeing programme
- In collaboration with Chief Audit Executive responsible for managing all internal audit activities Responsibilities include conducting annual risk analysis, …
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- GraphcoreBristol
- Annual leave
- Employee assistance programme
- Company pension
- Private medical insurance
- In addition to a competitive salary, Graphcore offers flexible working, a generous annual leave policy, private medical insurance and health cash plan, a dental…
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- Knowledge of EU MDR, FDA AI/ML regulatory frameworks, or broader international AI medical device regulations.
- MHRA AI Regulatory Specialist – Contract.
- HaleonWeybridge
- To ensure and enable a compliant organisation and robust inspection readiness across RDP by providing risk and compliance oversight, coordinating governance for…
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- HaleonSaint George's
- Support and conduct GCP, GLP, and GVP audits as a lead auditor for assigned audits or as a team member, including internal processes, investigator sites,…
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- NovartisLondon
- Step into a role where your judgment, curiosity, and clinical operations expertise can directly influence quality, compliance, and ultimately patient impact…
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- SGSFrimley
- Flexible schedule
- Detailed understanding of global medical device Regulations and good analysis capacity to detect discrepancy or issues.
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- SGSWrexham LL13
- Flexible schedule
- Extensive working knowledge of (in vitro diagnostic) medical device management systems, in vitro diagnostic medical device compliance and auditing and technical…
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- SGSGlasgow G81 2LG
- Annual leave
- Company pension
- Discounted gym membership
- SGS’s Life Sciences services support the pharmaceutical, biotech, and healthcare sectors with expert testing, clinical research, auditing, and certification—…
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Job Post Details
Quality Auditor - job post
Job details
Job type
- Full-time
Location
Full job description
Overview
The Quality Auditor drives the development and implementation of quality systems and process improvements to ensure compliance with standards and reduce inefficiencies. The role fosters a culture of continuous improvement by playing a leading role conducting cross-functional audits, identifying areas of risk and best practice, and supporting team development in quality practices.
Your role
- Support execution of the audit programme. Conduct regular internal audits, produce reports, support Root Cause Analysis of NCR's, and track follow on actions through to completion.
- Identify areas of risk to the business and support implementation of effective mitigation measures where required.
- Enhance quality documentation, procedures, and processes in line with standards and regulations.
- Undertake observer role during execution of external audits on CPS.
- Monitor implementation of the Quality Plan across the business and verify that requirements are being met.
- Evaluate and provide feedback on tender reviews in terms of Quality.
- Lead cross functional quality improvement initiatives, and provide training so teams are better equipped to drive quality throughout the business.
- Promote a culture of quality excellence and continuous improvement, ensure lessons learnt are captured, and promote behaviours aligned with quality objectives.
- Take ownership of personal development goals and mentor team members in quality principles.
About you
Qualifications/ skills/ experience
- A relevant professional qualification, ideally a Quality Assurance professional certified to ISO9001 or similar qualification with a recognised UK institution.
- Proven experience in quality assurance, quality control, or process improvement roles within complex contractual environments.
- Experience of auditing, report writing, root cause analysis and managing non-conformances.
- Strong knowledge of quality standards and methodologies (ISO 9001. Lean, Six Sigma).
- Strong stakeholder influencing and management skills.
- Experience in driving continuous improvement initiatives.
Personal attributes
- Detail-oriented with a strong focus on accuracy and precision.
- Proactive, resilient, and capable of working both autonomously and with teams to resolve quality issues.
- Ethical and objective, committed to fostering a culture of quality, integrity and continuous improvement.
- Adaptable and resilient, able to manage change and respond to evolving standards.
- Collaborative team player who works effectively across departments.
Behaviour
- Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers. Actively collects customer information and uses it to improve services and solutions. Manages the experience of customers to ensure positive relationships are established and maintained.
- Focus on Excellence: Willing to go the extra mile to exceed expectations. Continually searches for ways to add value and take performance to the next level.
- Teamwork & Collaboration: Puts aside personal agendas to work for the benefit of customers and suppliers and other stakeholders. Proactively builds knowledge through sharing knowledge, ideas, and expertise with others.
- Respect: Recognise and value our customers and people by encouraging and engaging.
- Trust: Be open and honest with all our customers and each other, reliable and predictable (no surprises) and approach everything we do with a 'can-do' attitude.
Rewards & benefits
Explore the rewards and benefits that help you thrive – at every stage of your life and your career. Enjoy competitive salaries, employee rewards and a brilliant range of benefits you can tailor to suit your own health, wellbeing, financial and lifestyle choices. Make the most of a myriad of opportunities for training and professional development to grow your skills and expertise. And combine our hybrid working culture and flexible holiday allowances to balance a great job and fulfilling personal life.
Rewards and benefits – Careers at AtkinsRéalis
About AtkinsRéalis
We're AtkinsRéalis, a world-class engineering services and nuclear organization. We connect people, data and technology to transform the world's'infrastructure and energy systems. Together, with our industry partners and clients, and our global team of consultants, designers, engineers and project managers, we can change the world. We're committed to leading our clients across our various end markets to engineer a better future for our planet and its people.
Additional information
Security clearance
This role may require security clearance and offers of employment will be dependent on obtaining the relevant level of clearance. If this is necessary, it will be discussed with you at interview. The vetting process is delivered by United Kingdom Security Vetting (UKSV) and may require candidates to provide proof of residency in the UK of 5 years or longer. If applying to this role please do not make reference to (in conversation) or include in your application or CV, details of any current or previously held security clearance.
We are committed to creating a culture where everyone feels that they belong - a place where we can all be ourselves, thrive and develop to be the best we can be. So, we offer a range of family friendly, inclusive employment policies, flexible working arrangements and employee resource groups to support all employees. As an Equal Opportunities Employer, we value applications from all backgrounds, cultures and ability. As a Disability Confident Leader, we are committed to offering an interview to all applicants who have a disability and meet the essential criteria. If you would like to be considered under this commitment, please let us know at the application stage.
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