Quality Compliance Lead — Medical Devices (ISO13485 & Audits)

Biocomposites; Keele; On-site; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Company events

Company pension

Employee discount

Free or subsidised travel

Free parking

On-site parking

Job summary

Biocomposites Keele is seeking a Quality Compliance Lead to own the QMS/eQMS and ensure regulatory compliance with ISO 13485, MDSAP, GMP and FDA standards. You will lead internal audits and drive continuous improvement.

You will manage a quality team, develop training, review documentation, and support supplier and regulatory audits. Some travel is required to support global operations in a fast‑moving medical devices environment.

Qualifications

• Level 6 qualification or equivalent experience in a regulated science field
• Minimum 6 years quality management experience in Pharmaceutica/Medical Devices
• Knowledge of ISO13485 quality management systems
• Lead auditor certification
• Experience with regulatory inspections and customer audits
• Familiarity with ERP and electronic document management systems
• Excellent communication skills
• People management skills
• Ability to meet deadlines and attention to detail

Responsibilities

• Lead and maintain QMS and eQMS compliance.
• Ensure adherence to regulatory requirements, customer standards and industry regulations (ISO 13485, MDSAP, GMP, FDA).
• Plan, coordinate and lead internal quality audits and support external audits and inspections.
• Plan, coordinate and lead supplier audits.
• Monitor processes against procedures and regulatory requirements; identify areas for improvement.
• Monitor quality system performance via KPIs and report trends to management.
• Review and approve quality documentation.
• Drive continuous improvement initiatives using QA methodologies.
• Deliver quality training and promote awareness of quality system requirements.
• Maintain quality records and document retention.
• Stay informed of changes to relevant regulations and standards.
• Manage and develop the quality team; travel nationally and internationally.

Skills

Excellent communication

People management

Lead auditor certification

Education

Level 6 within a science regulated industry or relevant experience

Tools

ERP systems

eQMS software

Job description

Biocomposites Keele is seeking a Quality Compliance Lead to own the QMS/eQMS and ensure regulatory compliance with ISO 13485, MDSAP, GMP and FDA standards. You will lead internal audits and drive continuous improvement.

You will manage a quality team, develop training, review documentation, and support supplier and regulatory audits. Some travel is required to support global operations in a fast‑moving medical devices environment.