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.
Key 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 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 and a discretionary annual bonus
- 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 up to £1,000 for each successful hire you recommend