Medical Device Quality Engineer
- 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
- 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, and one or more programming languages
- 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
- 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
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