The Quality Engineer will support the Quality team in maintaining the Quality System and ensuring compliance with customer, regulatory, and internal requirements.
Responsibilities include managing quality metrics, supporting validation, production, and risk management activities, and overseeing multiple projects from product inception to production.
The role involves collaborating with the team to uphold high standards across production lines, including inspection, testing, and continuous monitoring of product and process performance.
The Quality Engineer will ensure products meet quality, compliance, design control, risk management, and regulatory requirements.
What you'll do
Work closely with product development engineering and the client team to establish the product specifications and product specific requirements.
Perform an active role in quality planning and new product introduction from a QA perspective.
Compile and report quality metrics.
Support regulatory, internal and customer audits.
Support equipment and process validation activities including generation / updates to MVP.
Ensure compliance across projects for design control, risk management, and change control processes.
Manage quality engineering activities from receiving to final release, including but not limited to validation, testing, and continuous monitoring of product/process performance using applicable sampling and statistical techniques.
Support Quality culture within the organisation while providing training and guidance on applicable requirements / standards.
Provides manufacturing line support and provide Quality expertise in relation to Manufacturing issues and product disposition.
What we're looking for
Degree in Quality or Degree in Science / Engineering.
Experience within a similar role as quality engineer would be an advantage.
3+ years of industry experience in a medical device-manufacturing or pharmaceutical environment.
Working knowledge of FDA and ISO Quality systems for Medical device companies.
New product introduction and manufacturing process transfer experience would be an advantage.
Quality experience in component and device manufacturing desirable.
Proficient in MiniTab (or equivalent statistical software) and Microsoft Office applications e.g. Outlook, Word, Excel, Visio, PowerPoint, and Teams.
Strong interpersonal skills and the ability to communicate appropriately with different engineering teams, management, vendors and customers.
Ability to manage and control multiple activities.
Excellent attention to detail & organisation skills required.
Why Join IC...
At IC, we believe our people are the key to our success.
We provide an environment where curiosity, innovation, and growth are encouraged — and where you'll have the opportunity to make a real impact in the medical device industry.
Bike to work scheme
Company events
Company pension
Employee assistance program
On-site parking
Private medical insurance
Sick pay
If you're driven, eager to learn, and ready to grow your career in a fast-paced and supportive environment, we'd love to hear from you.
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