Quality Manager: Build ISO 13485 at Bristol Science Hub

Carbometrics Ltd; West of England; Presencial; GBP 50 000 - 55 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Lead quality function

Science Creates Bristol location

Pathway to regulatory submission

Resumo da oferta

Carbometrics Ltd in Bristol is seeking a hands-on Quality Manager to own and scale the ISO 13485 QMS from the ground up. You will work independently in a small team and guide audits, CAPAs and supplier quality as the company grows toward regulatory submission and product launch.

This on-site role at Science Creates, Bristol, offers the chance to shape quality processes for a fast-growing glucose-sensing technology company and collaborate with scientists and engineers.

Qualificações

• Proven experience implementing and/or managing a QMS in a regulated environment (ISO 13485/9001).
• Experience owning document control, record-keeping and change control to a high standard.
• Experience planning internal audits and hosting external certification assessments.
• Experience managing non-conformances, CAPAs and root-cause investigations to closure.

Responsabilidades

• Own the ISO 13485 QMS introduction and ongoing maintenance, including document control and change control.
• Define and improve quality processes and forms for a growing start-up.
• Lead internal audits and host external audits or certifications.
• Manage non-conformances, CAPAs and root-cause investigations.
• Support QC testing and incoming material inspections as needed.

Conhecimentos

QMS implementation

Audits & compliance

CAPA & root cause

Documentation & SOPs

Stakeholder management

Attention to detail

Independent worker

Quality culture

Formação académica

BSc in Life Sciences / Chemistry / Biomedical or Chemical Eng

MSc in Quality Management or ISO lead auditor training

Ferramentas

MS Office

SharePoint

Descrição da oferta de emprego

Carbometrics Ltd in Bristol is seeking a hands-on Quality Manager to own and scale the ISO 13485 QMS from the ground up. You will work independently in a small team and guide audits, CAPAs and supplier quality as the company grows toward regulatory submission and product launch.

This on-site role at Science Creates, Bristol, offers the chance to shape quality processes for a fast-growing glucose-sensing technology company and collaborate with scientists and engineers.