Quality Engineer

Description:

About the Role

We are looking for a Quality Engineer to join a Medical Device manufacturing company in North Wales. This is an excellent opportunity for a quality professional who is passionate about compliance, continuous improvement, and delivering products that make a meaningful difference to patients' lives.

As a Quality Engineer, you will play a key role in ensuring our products and processes meet the highest quality and regulatory standards. You will work closely with manufacturing, engineering, R&D, and global quality teams to support quality management activities, investigations, risk management, and process improvement initiatives.

What You'll Be Doing

Supporting and improving the site's Quality Management System (QMS)
Developing, reviewing, and maintaining quality procedures, work instructions, and records
Participating in internal and external quality audits
Supporting product and process quality activities throughout the product lifecycle
Contributing to design reviews, verification, validation, and design transfer activities
Supporting process validation activities (IQ/OQ/PQ)
Conducting risk assessments and maintaining risk management documentation in line with ISO 14971
Investigating product and process non-conformities
Leading root cause investigations and supporting CAPA activities
Helping ensure compliance with applicable medical device regulations and quality standards
Analysing quality data, trends, and performance metrics
Leading or supporting continuous improvement projects using Lean Six Sigma methodologies
Collaborating with cross-functional stakeholders to drive quality and operational excellence

About You

To be successful in this role, you will ideally have:

A degree (or equivalent experience) in Engineering, Science, or a related discipline
At least 2 years' experience in a Quality Engineering, Quality Assurance, or similar role
Experience working within a regulated manufacturing environment
Knowledge of Quality Management Systems (QMS)
Understanding of CAPA and non-conformance processes
Experience using data analysis tools such as Excel (Minitab experience is advantageous)
Strong problem-solving and root cause analysis skills
Excellent communication and stakeholder management abilities
Ability to work effectively across multidisciplinary teams
Knowledge of change control and validation processes would be beneficial
Experience with FMEA or other risk management tools would be advantageous
Six Sigma Green Belt qualification, or experience applying quality engineering tools and techniques, would be desirable

Why Join Us?

Be part of a global organisation that develops products which improve patient outcomes and quality of life
Work within a collaborative and supportive quality team
Gain exposure to medical device quality systems and regulatory requirements
Opportunity to lead improvement projects and shape manufacturing quality performance
Competitive salary and benefits package
Career development and progression opportunities

Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy