Quality Manager (ISO 13485): QMS Builder

Hireful; West of England; On-site; GBP 50,000 - 55,000; Full time

Benefits offered by this job

Base at Science Creates Bristol

Lead quality function

Grow with startup

Job summary

Carbometrics, a Bristol-based chemistry company, is building an ISO 13485 QMS to support our glucose-sensing platform. We seek a hands-on Quality Manager to lead quality from the ground up, collaborate with consultants, and shape quality practices as we prepare for regulatory submission and product launch.

This senior role requires independent work, strong project management, and the ability to drive CAPAs, supplier quality, and documentation across a small cross-functional team.

Qualifications

• Proven experience implementing/managing a QMS in a regulated environment (ISO 13485/9001).
• Experience owning document control, records, and change control processes to high standard.
• Experience planning/leading internal audits and hosting external audits or certifications.
• Experience handling non-conformances, root-cause investigations and CAPAs to closure.
• Strong numeracy and written communication, attention to detail.

Responsibilities

• Own ISO 13485 QMS implementation and ongoing maintenance, including document control and change control.
• Define and improve quality processes, procedures and forms for a growing startup.
• Chair management review meetings and ensure actions are completed.
• Plan/lead internal audits and support external audits and certifications.
• Manage non-conformances, CAPAs, and supplier quality.

Skills

QMS management

Document control

Quality documentation

Audits

Stakeholder management

Attention to detail

MS Office

Independent work

Lab experience

Manufacturing exp

Education

BSc in Life Sciences / Chemistry / Biomedical

MSc in Quality Management

Tools

SharePoint

Excel

Word

PowerPoint

Job description

Carbometrics, a Bristol-based chemistry company, is building an ISO 13485 QMS to support our glucose-sensing platform. We seek a hands-on Quality Manager to lead quality from the ground up, collaborate with consultants, and shape quality practices as we prepare for regulatory submission and product launch.

This senior role requires independent work, strong project management, and the ability to drive CAPAs, supplier quality, and documentation across a small cross-functional team.