Quality & Regulatory Engineer - Shape Safe Medical Devices

Crux Product Design Ltd; Bristol; On-site; GBP 40,000 - GBP 60,000; Full time

Job summary

A consultancy in medical device development is seeking a Quality & Regulatory Engineer to support their Bristol office. This essential role involves maintaining the ISO-certified Quality Management System, managing risks, and ensuring compliance with medical device regulations. Candidates should have a degree in a relevant field and strong experience in quality assurance. This position offers the chance to work on innovative medical projects, with opportunities for collaboration and travel for global project delivery.

Qualifications

• Strong relevant sector experience in Medical Device Quality Assurance and Regulatory Compliance.
• Awareness of medical device related standards, regulations and guidelines such as IEC 62366-1, ISO 14971, EU MDR, and FDA guidance.

Responsibilities

• Embed quality throughout product development.
• Support validation of QMS systems.
• Contribute to risk management activities.

Skills

Strong analytical and problem-solving skills

Excellent attention to detail

Effective communication skills

Education

A good degree in a relevant scientific/healthcare-related discipline

Job description

A consultancy in medical device development is seeking a Quality & Regulatory Engineer to support their Bristol office. This essential role involves maintaining the ISO-certified Quality Management System, managing risks, and ensuring compliance with medical device regulations. Candidates should have a degree in a relevant field and strong experience in quality assurance. This position offers the chance to work on innovative medical projects, with opportunities for collaboration and travel for global project delivery.