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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Skills Required
- Experience conducting or supporting internal and external audits, including FDA, Notified Body, or supplier audits
- Experience working in quality assurance within medical devices or healthcare
- Experience with CAPA, non-conformances, root cause analysis, change control, risk management, and statistical tools
- Degree or HNC/HND in Engineering; mechanical or biomedical engineering preferred
- Strong problem-solving, critical-thinking, communication, influencing, and stakeholder-engagement skills
- Knowledge of Lean, Six Sigma, and continuous-improvement methods
- Ability to plan and organize work to meet established schedules
- Ability to make decisions and exercise authority within established limits and approvals
What We Do
As a leader in orthopaedic innovation, Corin has pioneered a number of landmark developments since its foundation and is proud to have been able to improve the quality of life of thousands of patients around the world through these groundbreaking products. The company’s talented and dedicated teams share a common commitment to deliver quality orthopaedic products and services to patients, surgeons and healthcare providers which exceed expectations and positively impact lives. With an increasingly active and demanding patient population, the need to provide state of the art conservative treatment pathways, in addition to more traditional interventions, has never been more important. Corin’s product portfolio is designed to provide each patient with the optimal solution, utilising some of the most advanced technologies available in the world to enhance implant longevity and performance.
