Senior QA Engineer, Medical Devices–Compliance & Impact

Corin Group; Cirencester; Hybrid; GBP 42,000 - 49,000; Full time

Benefits offered by this job

Competitive salary

Discretionary annual bonus

Pension scheme

Life assurance

Private medical insurance

Eye tests and flu vaccinations

Employee referral program

Job summary

Corin Group in Cirencester is seeking a Senior Quality Engineer (QA) to drive quality excellence in a highly regulated medical devices environment.

You will apply FDA, ISO and MDR standards, lead investigations, improve processes and partner with stakeholders across the business to ensure robust quality systems and compliance.

The role includes supporting audits, CAPA/NCR handling, change control, and ongoing continuous improvement initiatives, with a competitive salary and benefits package.

Qualifications

• Experience in internal/external audits (FDA, Notified Body, supplier).
• QA in medical devices or healthcare environments.
• CAPA, NCRs, Root Cause Analysis, Change Control, Risk Management, and statistics.

Responsibilities

• Apply FDA, ISO, MDR and other regulatory standards across the business.
• Review manufacturing and quality activities; support major process and QMS changes.
• Develop and maintain compliant procedures and documentation; deliver training.
• Support metrics analysis including on-time trending and reporting.
• Lead NCR and CAPA processes; data capture and root cause investigations.
• Promote adherence to SOPs and global objectives for timeliness.
• Assist with internal/external audits; present QA systems.
• Assist product complaint investigations and quality improvements.
• Participate in management reviews, change control, and compliance meetings.
• Champion continuous improvement and QA behaviours.
• Adhere to QMS per ISO13485 and FDA Part 820.

Skills

Audits experience

QA in medical devices

CAPA & NCRs

Root cause analysis

Change control

Risk management

Statistical tools

Problem solving

Lean Six Sigma

Influencing leadership

Planning & organizing

Decision making

Education

Engineering degree

Job description

Corin Group in Cirencester is seeking a Senior Quality Engineer (QA) to drive quality excellence in a highly regulated medical devices environment.

You will apply FDA, ISO and MDR standards, lead investigations, improve processes and partner with stakeholders across the business to ensure robust quality systems and compliance.

The role includes supporting audits, CAPA/NCR handling, change control, and ongoing continuous improvement initiatives, with a competitive salary and benefits package.