Regulated QA Engineer – Medical Devices (ISO13485/GMP)

Corin Group; Cirencester; Hybrid; GBP 34,000 - 42,000; Full time

Benefits offered by this job

Salary £34-42k contingent on exp.

Pension 6% to 9.7%

Life assurance

Private medical (BUPA)

Eye tests and flu vaccinations

Employee referral bonus

Job summary

Corin Group is seeking a proactive QA Quality Engineer to bolster the Quality Assurance function. You will ensure products and processes meet ISO13485 and GMP standards while supporting cross‑functional teams in investigations, documentation and continuous improvement.

You will review SOPs and specs, assist with audits, and help manage CAPA/NCR activities. A GMP environment background and strong analytical skills are essential.

Qualifications

• Experience in a highly regulated environment such as medical devices, pharma, aerospace or automotive.
• Knowledge of core Quality concepts (CAPA, NCRs, revision control, RCA).
• Hands-on quality engineering experience in a GMP/GxP setting.
• Familiarity with Quality Management Systems (QMS) and regulatory standards.

Responsibilities

• Evaluate manufacturing and quality processes for ISO 13485, GMP and FDA 21 CFR 820 compliance.
• Support investigations, documentation, and continuous improvement with cross-functional teams.
• Assist with NCRs, root cause analysis and risk management activities.
• Support internal audits and review/approve SOPs and product/equipment specs.
• Maintain quality dashboards and KPIs.

Skills

Regulated environment

CAPA & NCRs

Root cause analysis

Analytical thinking

Decision making

Influencing

Planning & organizing

Education

Engineering degree

Engineering background

Job description

Corin Group is seeking a proactive QA Quality Engineer to bolster the Quality Assurance function. You will ensure products and processes meet ISO13485 and GMP standards while supporting cross‑functional teams in investigations, documentation and continuous improvement.

You will review SOPs and specs, assist with audits, and help manage CAPA/NCR activities. A GMP environment background and strong analytical skills are essential.