At a Glance
- Tasks: Audit and certify quality management systems for innovative healthcare companies.
- Company: Join a leading Healthtech company focused on quality and compliance.
- Benefits: Competitive salary, flexible working hours, and opportunities for professional growth.
- Other info: Dynamic team environment with a focus on innovation and continuous improvement.
- Why this job: Make a real impact in the healthcare industry by ensuring product quality and safety.
- Qualifications: Bachelor’s degree in engineering or related field with experience in medical devices.
The predicted salary is between 50000 - 65000 £ per year.
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.
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 6234, IEC 82304, etc.), software development methodologies, cyber security, etc.
DESIRABLE SKILLS
- Work experience – Experience working with ISO 27001.
- Analytical reader – Comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information.
- Ferociously curious – Enjoy going down rabbit holes, understanding deeply how things work, and challenging the status quo.
- Highly adaptable – Have worked in different environments and like operating with autonomy on sometimes ambiguous tasks.
INTERVIEW PROCESS
- Recruiter screen and intro call with hiring manager – 45 minutes.
- Regulatory and auditor skills interview with Quality Team – 45 minutes.
- Cross‑functional problem‑solving interview with Operations Team – 45 minutes.
- Founder interviews – two 30‑minute sessions.
- References.
- Offer.
Medical Device Quality Engineer London employer: Meeveem Limited
Meeveem Limited is an exceptional employer that values its employees by fostering a collaborative and innovative work culture in the heart of Yorkshire. With a strong focus on professional development, employees are encouraged to grow their skills and advance their careers while enjoying competitive benefits and a supportive environment that prioritises work-life balance. Joining Meeveem means being part of a dynamic team dedicated to making a meaningful impact in the cardiovascular and endovascular sectors.
