Medical Device Quality Engineer

Job not on LinkedIn

🕒 March 27

🇬🇧 United Kingdom – Remote

💵 £60k - £80k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Scarlet

WebsiteLinkedInAll Job Openings

1 - 10 employees

📚 Education

👥 HR Tech

⚡ Productivity

Education • HR Tech • Productivity

Scarlet is a company dedicated to leadership development across various stages of life. It offers customized courses and tips for both in-person and virtual formats to help leaders elevate their skills and make a real impact. Scarlet provides training in areas such as intern etiquette, business networking, presentation skills, and socializing effectively in business environments. The company emphasizes personal growth, authentic communication, and unlocking leadership potential. Scarlet aims to support individuals in navigating life and leadership with confidence and skill.

📋 Description

• 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

🎯 Requirements

• Bachelor’s degree in engineering, software engineering, computer science, physics or equivalent • Minimum of four years of professional experience in the field of medical devices • Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971, etc.) • Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU MDR, ISO 14971, etc.) • 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: • Experience working with ISO 27001 • You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information • You like going down rabbit holes, understanding deeply how things work, and challenging the status quo • You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks

🏖️ Benefits

• Offers Equity