IVD Quality Systems Lead — Build ISO 13485 QMS

CAPU Search Ltd; England; On-site; GBP 60,000 - 80,000; Full time

Job summary

CAPU Search Ltd is partnering with an early-stage IVD company in Oxfordshire that needs a Quality Manager to build their QMS from the ground up. You will lead gap assessments, select and implement an eQMS, and drive ISO 13485 readiness ahead of IVDR and FDA submissions.

Reporting to the COO, you’ll steer a small team of scientists and engineers in a startup where processes are created as you go. Expect on-site work at least three days per week, with a salary of £60,000–£80,000 DOE.

Qualifications

• IVD experience required, with prior involvement in ISO 13485.
• 5+ years around ISO 13485; hands-on in building or rebuilding a QMS.
• Solid knowledge of 14971, IVDR, and 21 CFR 820.
• Hands-on with eQMS; experience selecting one.
• CSV/Software validation including IQ/OQ/PQ.
• Comfortable in a startup with undefined swim lanes.

Responsibilities

• Lead the design and implementation of the QMS from ground up, including gap assessments and roll-out.
• Drive ISO 13485 readiness and plan for IVDR/FDA submissions.
• Collaborate with COO and cross-functional teams of scientists and engineers.
• Train staff on QMS processes and maintain compliance with regulatory standards.

Skills

IVD experience

ISO 13485 experience

Regulatory knowledge (IVDR, 21 CFR 820

eQMS implementation

CSV validation (IQ/OQ/PQ)

Startup environment adaptability

Supplier audits

QMS build/lead

Tools

eQMS

Job description

CAPU Search Ltd is partnering with an early-stage IVD company in Oxfordshire that needs a Quality Manager to build their QMS from the ground up. You will lead gap assessments, select and implement an eQMS, and drive ISO 13485 readiness ahead of IVDR and FDA submissions.

Reporting to the COO, you’ll steer a small team of scientists and engineers in a startup where processes are created as you go. Expect on-site work at least three days per week, with a salary of £60,000–£80,000 DOE.