Senior Quality Engineer

Role Overview

We are looking for an experienced Senior Quality Engineer to join our Client in Diss. 

This is a hands-on role supporting manufacturing operations and ensuring our products, processes and quality systems meet customer, regulatory and statutory requirements.

You will help maintain and improve the company’s integrated Quality, Environmental, Health and Safety Management System, lead quality investigations and work closely with teams across the business to improve product quality, compliance and operational performance.

Key Responsibilities

Quality Management Systems

Support the maintenance and ongoing improvement of the integrated Quality, Environmental, Health and Safety Management System.
Help ensure continued compliance with ISO 13485, ISO 9001, ISO 14001 and ISO 45001.
Create, review and update quality procedures, work instructions and supporting documentation.
Carry out internal audits and assist with customer, certification and regulatory audits.
Monitor quality performance and produce clear KPI, trend and performance reports.
Promote practical improvements and good quality practices across the business.

Quality Engineering

Lead investigations into customer complaints and manage associated Corrective and Preventive Action activities.
Make sure corrective actions are implemented effectively, verified and completed within agreed timescales.
Carry out structured root cause investigations using recognised problem-solving methods.
Manage internal calibration activities and ensure measuring equipment remains suitable and compliant.
Support supplier approval, auditing, performance monitoring and improvement activities.
Develop, review and approve purchased product control plans.
Support manufacturing risk management activities, including Process FMEA.
Manage process verification and validation activities.
Support the programming and use of optical measuring systems for incoming inspection.
Provide quality engineering support for day-to-day manufacturing, continuous improvement projects and new product introductions.
Work closely with Operations, Engineering, Supply Chain, Research and Development and other departments.
Undertake other reasonable duties that support the needs of the business.

Initial Priorities

During the first few months, the successful candidate will focus on:

Improving quality reporting and trend analysis to support better decision-making.
Managing day-to-day technical quality activities, including documentation, calibration, verification and validation.
Resolving customer complaints and progressing CAPA activity in a timely and effective manner.
Supporting successful internal and external audits.
Ensuring continued compliance with relevant quality and regulatory standards.

Longer-Term Objectives

Lead improvement projects that strengthen product quality, operational performance and customer satisfaction.
Improve supplier quality, risk management and quality system processes.
Help develop quality systems that support future growth and ongoing regulatory compliance.

Essential Experience and Skills

Experience in Quality Engineering, Quality Assurance or Quality Systems within a regulated manufacturing environment.
A strong understanding of Quality Management Systems.
Experience carrying out internal audits.
Practical knowledge of CAPA, root cause analysis and structured problem-solving tools, including 4D.
Good metrology knowledge and experience.
Strong analytical and problem-solving ability.
A high level of accuracy and attention to detail.
Ability to read and interpret engineering drawings, specifications and technical standards.
Clear written and verbal communication skills.
Good working knowledge of Microsoft Office, particularly Excel.
A full UK driving licence.

Desirable Experience

A degree in Engineering, Science, Manufacturing or a related subject.
Experience within medical device manufacturing.
Detailed working knowledge of ISO 13485.
A recognised Internal Auditor qualification.
Knowledge of ISO 14971 risk management requirements.
Experience developing Process FMEAs.
Experience managing process verification and validation activities.
Supplier quality management and supplier auditing experience.
Project leadership or project management experience.
Experience managing customer complaints, post-market surveillance or vigilance activities.

Personal Qualities

Confident communicating with colleagues, suppliers and customers.
Organised, dependable and able to manage competing priorities.
Comfortable working independently while remaining an effective team member.
Able to make sound decisions and resolve problems in a practical way.
Committed to improving quality, systems and ways of working