Quality Engineer
Location: Liverpool - Must be happy to travel to Chester
The Opportunity
We are seeking an experienced Quality Engineer to join a medical device manufacturing environment near Liverpool. The role will focus on maintaining and improving product and process quality, supporting the Quality Management System (QMS), risk management, validation, CAPA and nonconformance activities, while driving continuous improvement across manufacturing operations.
You will work closely with Engineering, Manufacturing, R&D and Global Quality teams to ensure products and processes remain compliant with applicable regulatory requirements and quality standards.
Key Responsibilities
- Maintain and improve the Quality Management System (QMS) in line with applicable regulatory requirements.
- Develop, review and update quality procedures, work instructions and records.
- Support internal and external quality audits.
- Ensure products meet defined quality requirements throughout their lifecycle.
- Participate in design control activities, including design reviews, verification and validation, and design transfer.
- Support process validation activities, including IQ/OQ/PQ.
- Conduct and maintain risk management files in accordance with ISO 14971.
- Perform risk assessments and support the implementation of risk mitigation actions.
- Investigate product and process nonconformities and lead Root Cause Analysis (RCA) activities.
- Manage and monitor Corrective and Preventive Actions (CAPA).
- Support regulatory submissions and inspections and ensure compliance with global medical device regulations.
- Maintain documentation required for audits and regulatory reviews.
- Analyse quality metrics and trends to identify opportunities for improvement.
- Lead continuous improvement initiatives using Lean Six Sigma methodologies.
- Drive improvements in manufacturing efficiency and product quality.
- Work collaboratively with cross-functional teams to deliver quality and improvement projects.
About You
We are looking for someone with:
- 2+ years' experience in a similar Quality Engineering role; medical device experience is preferred but not essential.
- An understanding of medical device regulatory requirements.
- Basic knowledge and practical experience of CAPA and nonconformance (NC) processes.
- Basic understanding and experience of eQMS systems or similar.
- Statistical experience using Excel, with MINITAB experience preferred.
- Strong interpersonal and communication skills, with experience deploying projects across cross-functional teams.
- An understanding of Six Sigma Green Belt principles and/or demonstrated ability to use quality engineering tools, quality core tools and data interpretation.
- Practical knowledge of change control and, preferably, the process and computer systems validation lifecycle.
- Demonstrated ability to lead projects, motivate cross-functional teams and ensure deadlines are achieved.
- Experience implementing or reviewing pFMEA or similar risk assessment methodologies.
- A degree or equivalent experience in Science, Engineering or a related discipline.
- Knowledge of validation, regulatory and compliance requirements.
- Knowledge and experience working with a Quality Management System within medical device manufacturing.