Senior Quality Assurance Engineer

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

Job Description

Posted Friday, 4 September 2026 at 00:00

Senior Quality Engineer (QA)

Location: Cirencester onsite Mon – Fri • Department: Quality Assurance

Join Corin as a Senior Quality Engineer and help drive quality excellence across a highly regulated, innovative environment. You’ll use your knowledge of FDA, ISO, and MDR standards to support compliance, lead investigations, improve processes, and partner with stakeholders across the business.

What you'll do

• 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 Departmental metric analysis including on-time trending and reporting, ensuring Quality KPIs and targets are met.
• Support/lead non-conformance (NCR) and Corrective & Preventive Action (CAPA) processes as directed. Conduct and/or support data capture and root cause investigations, review actions for comprehensiveness, determine stock disposition, and analyze the data for the reasons of Quality Improvement and reporting.
• Promote and support adherence to Corin’s Standard Operating Procedures (SOPs) and Global Objectives for timeliness.
• Support internal and external audits; present QA systems confidently.
• Assist with product complaint investigations and quality improvement actions.
• Participate in Management Review, change control, and compliance meetings.
• Champion continuous improvement, stakeholder engagement, and strong QA behaviours.
• Adhere to Quality Management System (QMS) requirements in line with Corin’s Good Manufacturing Practice (GMP) and Good Documentation Practice (GDocP) as per ISO13485 & FDA21 CFR Part 820.

About You

• Experience in internal/external audits (e.g., FDA, Notified Body, supplier).
• Worked in QA within medical devices, or healthcare.
• Demonstrated experience of CAPA, NCRs, Root Cause Analysis, Change Control, Risk Management, and statistical tools.
• Degree or HNC/HND in Engineering (mechanical or biomedical preferred).
• Strong problem-solving, with critical thinking and communication skills.
• Knowledge of Lean/Six Sigma and continuous improvement methods.
• Influencing and leading - Develop a network of internal resources to facilitate completion of tasks. Ability to question and challenge is key.
• Planning and organizing: Complete daily work to meet established schedule.
• Driving decision making and making an impact: Exercise authority within pre ‐ established limits and approval

What's in it for you:

• A competitive salary dependant on experience £42,000 - £49,000 and a discretionary annual bonus of 7.5%
• Excellent pension – starts at 6%, going up to 9.7% after 18 months.
• Life assurance – Six times your basic salary
• Private medical insurance with BUPA for you and your family
• Free annual eye tests and flu vaccinations
• Employee referral program where you can earn from £1,000 for each successful hire you recommend

IND007

Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.