Design Quality Partner - Medical Devices

F. Hoffmann-La Roche Gruppe; Scotland; On-site; GBP 125,000 - 150,000; Full time

Job summary

A leading healthcare company in Scotland seeks a Design Quality Partner to oversee quality in medical device development. Your role will involve ensuring design control deliverables, reviewing documentation, and standardising processes. The ideal candidate will have a relevant degree and strong knowledge of quality management systems. This position offers an opportunity to make a significant impact in improving healthcare outcomes.

Qualifications

• Degree in engineering, business administration, or a related field required.
• Strong understanding of design control and medical Quality Management Systems.
• Knowledge of regulatory standards like ISO 13485, FDA, and GMP.

Responsibilities

• Partner closely with project teams to ensure design control deliverables are complete.
• Review and approve development documentation for accuracy and compliance.
• Drive standardisation across projects including templates and processes.
• Support and represent Pre-Market Quality in audits.
• Oversee design change requests and ensure timely resolution.

Skills

Strong understanding of design control and medical Quality Management Systems

Excellent communication and technical writing skills

Knowledge of regulatory standards such as ISO 13485, FDA, and GMP

Problem-solving

Collaboration

Education

Degree in engineering, business administration, or related field (MBA or advanced degree is an advantage)

Job description

A leading healthcare company in Scotland seeks a Design Quality Partner to oversee quality in medical device development. Your role will involve ensuring design control deliverables, reviewing documentation, and standardising processes. The ideal candidate will have a relevant degree and strong knowledge of quality management systems. This position offers an opportunity to make a significant impact in improving healthcare outcomes.