auditor medical devices iso 13485 Work, Jobs (with Salaries)

Medical Device Quality Engineer
Scarlet —London
- £60,000 - £80,000 a year
- Full-time
- Hybrid work
- Computer Science
- Engineering
- Bachelor's degree
Medical Device Auditors
TUV Rheinland UK Ltd. —Solihull
- Full-time
- Hybrid work
- Engineering
- Maintenance
- Travel
- Employee discount
- Flexible schedule
Product Compliance Officer - Medical Devices
Mayborn Group —Newcastle upon Tyne
- Project management
- In-person
- Communication skills
- Health & wellbeing programme
- Work from home
Quick apply
Global QA Senior Manager, Medical Devices & Drug/Device Combined Products
Ferring Pharmaceuticals, Inc. —East Kilbride
- Full-time
- Project management
- Travel
Regulatory Education Specialist (Quality)
Scarlet —London
- £60,000 - £80,000 a year
- Full-time
- Remote
- Communication skills
- Teaching
Manager, Regulatory Affairs
Hyland Software —Remote
- Remote
- Microsoft Excel
- Windows
- Bachelor's degree
Quality Engineer
Corza Medical —Solihull
- Full-time
- Engineering
- Communication skills
Quality Engineer
CMR Surgical —Cambridge
- Hybrid work
- Bachelor's degree
- No degree
- Travel
- Annual leave
Quality Manager
Liverpool University Hospitals NHS Foundation Trust —Liverpool
- £39,959 - £48,117 a year
- Full-time
- Rehabilitation centre
- IT
8d
Quality Engineer
CooperVision —Fareham
- Full-time
- Microsoft Outlook
- Computer literacy
- Travel
Post Market Complaints Data Analyst
Convatec —London
- Full-time
- Remote
- Microsoft Excel
- Master's degree
- Leadership

I want to receive the latest job alerts for auditor medical devices iso 13485

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Medical Device Quality Engineer

Scarlet
London

Apply Now

Job details

Full-time
£60,000 - £80,000 a year

Qualifications

Computer Science
Engineering
Quality management
Bachelor's degree

Full job description

Our mission is to hasten the transition to universally accessible healthcare. We are authorised by governments to assess and grant market access to medical AIs. Our groundbreaking approach enables the most innovative technology to reach patients safely and quickly.

Scarlet is the pre-eminent authority on AI medical devices. We serve customers that matter. Companies building bleeding-edge medical AI systems choose Scarlet. We are proud to count the world’s best resourced and most ambitious companies building medical AI as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue.

Come help us bring the next generation of healthcare to the people who need it.

About this role:

Scarlet’s Quality Team plays a pivotal role in ensuring that Medical Device Manufacturers meet and exceed the Quality Management System (QMS) requirements laid out by the regulators. With deep expertise in regulatory standards, the team designs efficient workflows that enable timely and secure QMS audits of the next generation of Healthtech products.

The Quality Team's goal is to ensure full compliance and operational excellence—both within Scarlet and for Medical Device Manufacturers.

Your responsibilities:

Get authorised to audit and certify the quality management systems of the most innovative healthcare companies in the world
Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.)
Optimise the assessment of customer data by designing efficient audit processes
Be involved in maintaining and expanding Scarlet’s approvals in various jurisdictions and technologies

The key skills:

Education - Bachelor’s degree in engineering, software engineering, computer science, physics or equivalent
Work experience - Minimum of four years of professional experience in the field of medical devices
Work experience - Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971, etc.)
Work experience - Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU MDR, ISO 14971, etc.)
Technical experience - Minimum one year of practical experience working with medical device software, demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security etc.

Desirable skills:

Work experience - Experience working with ISO 27001
Analytical reader - You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information
Ferociously curious - You like going down rabbit holes, understanding deeply how things work, and challenging the status quo
Highly adaptable - You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks

The Interview Process

At Scarlet, we have built our interview processes to ensure you get to fully understand the role and Scarlet’s culture, and to ensure we get to know about your skills, expertise, and who you are. Here is what to expect:

Recruiter Screen and Intro call with Hiring Manager - 45 mins
Regulatory and Auditor Skills Interview with Quality Team - 45 mins
Cross-functional Problem Solving Interview with Operations Team - 45 mins
Founder Interviews - 2x30 mins
References
Offer

Compensation Range: £60K - £80K

Apply Now

Refine Your Search

auditor medical devices iso 13485 jobs

Medical Device Quality Engineer

Medical Device Auditors

Product Compliance Officer - Medical Devices

Global QA Senior Manager, Medical Devices & Drug/Device Combined Products

Regulatory Education Specialist (Quality)

Manager, Regulatory Affairs

Quality Engineer

Quality Engineer

Quality Manager

Quality Engineer

Post Market Complaints Data Analyst

I want to receive the latest job alerts for auditor medical devices iso 13485

Explore jobs in more locations

About this role:

Your responsibilities:

The key skills:

Desirable skills:

The Interview Process

Jobseeker tools

Employer Tools

Browse

Stay Connected