Quality Engineer – Medical Devices (ISO 13485 & Audits)

Matchtech; Fareham; Hybrid; GBP 40,000 - 55,000; Full time

Benefits offered by this job

Hybrid working

27 days holiday

40-hour week

Pension match

Share scheme

Cycle to work

Dental scheme

Company lunch Thursdays

Job summary

Matchtech is assisting a medical device business near Fareham, Hampshire, to recruit a Quality Engineer focused on quality systems, compliance and audits. The role is permanent and hybrid, emphasizing audit readiness, CAPA, and embedded quality processes across the organisation.

You will work within a regulated medical device environment, applying ISO 13485, ISO 14971 and ISO 9001 principles while collaborating with stakeholders to maintain and improve the QMS.

Qualifications

• Experience in Quality Engineering or Quality Compliance within the medical device sector.
• Strong working knowledge of ISO 13485 and understanding of ISO 14971.
• Knowledge of ISO 9001, quality management systems and regulatory compliance.
• Experience supporting internal and external audit cycles for medical device products.
• Understanding of CAPA, document control, quality risk management and continuous improvement.

Responsibilities

• Maintain and improve digital and paper-based elements of the Quality Management System.
• Plan, conduct and report on internal audits.
• Support external audit readiness, including evidence packs, responses and follow-up actions.
• Support compliance with ISO 13485 and quality risk activities aligned with ISO 14971.
• Apply knowledge of ISO 9001 and quality engineering principles within a regulated medical device environment.
• Manage controlled updates to procedures, forms and quality records.
• Support CAPA and continuous improvement activities arising from audits and quality findings.
• Work collaboratively with stakeholders to establish consistent and effective quality practices.

Skills

Quality Engineering

ISO 13485

CAPA

Regulatory compliance

Audit experience

Job description

Matchtech is assisting a medical device business near Fareham, Hampshire, to recruit a Quality Engineer focused on quality systems, compliance and audits. The role is permanent and hybrid, emphasizing audit readiness, CAPA, and embedded quality processes across the organisation.

You will work within a regulated medical device environment, applying ISO 13485, ISO 14971 and ISO 9001 principles while collaborating with stakeholders to maintain and improve the QMS.