Senior Quality Assurance Engineer

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%
25 days holiday plus bank holidays
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

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