Quality Auditor

Job not on LinkedIn

🔥 4 minutes ago

🇬🇧 United Kingdom – Remote

💵 £65k - £85k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔎 Auditor

🇬🇧 UK Skilled Worker Visa Sponsor

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👻 Ghost score 15%

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Logo of Scarlet

Scarlet

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

• Plan and conduct QMS audits against ISO 13485, EU MDR and UK MDR requirements. • Review records and interview teams to assess whether their processes meet the requirements. • Document evidence, findings and conclusions in clear, timely audit reports. • Explain findings constructively and keep customers informed throughout the audit. • Review corrective actions and the evidence needed to close findings. • Audit medical device manufacturers’ quality management systems and produce clear conclusions supporting certification decisions. • Help safe devices reach patients sooner.

🎯 Requirements

• A degree in a relevant scientific, engineering or medical discipline. • At least four years’ experience in the medical device industry, including two years auditing or managing an ISO 13485 QMS. • Working knowledge of EU MDR or UK MDR requirements for quality management systems. • Experience explaining audit findings or regulatory requirements clearly, in writing and in conversation. • Experience with software demonstrating knowledge of software design, validation, testing, debugging and interactions with its operating environment. • Experience conducting audits for a certification or notified body is preferred. • Experience with medical device software is preferred.

🏖️ Benefits

• Equity • Training in Scarlet’s audit methods and tools • Limited travel, with only occasional trips potentially required

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