Quality Engineer – Medical Device Manufacturing
My client, a leading contract manufacturer medical device, serving global healthcare companies, is seeking an experienced Quality Engineer to join their team.
About the Role
As a Quality Engineer, you will play a key role in ensuring the highest quality standards are met across production processes. Reporting to the Quality Engineering Manager, you will be responsible for maintaining and improving quality processes, conducting investigations, supporting product validations, and liaising with internal teams and customers.
Key Responsibilities:
- Provide ongoing quality support to maximise production performance and product integrity.
- Lead investigations into quality issues, identify root causes, and implement corrective actions.
- Ensure compliance with ISO 13485, ISO 14971, and FDA QSR 21 CFR Part 820 standards.
- Develop and maintain quality management systems, inspection plans, and risk assessments.
- Perform internal and external audits, including customer and regulatory body inspections.
- Support new product introduction (NPI) with process validations and documentation.
- Oversee non-conforming materials, CAPA investigations, and customer complaints.
- Train and mentor junior engineers, promoting a culture of continuous improvement.
Requirements:
- Education: Level 8 Degree in Engineering.
- Experience: Minimum three years’ experience in a Quality Engineering role, preferably in medical devices.
- Skills:
- Strong problem-solving and data analysis skills.
- Ability to work cross-functionally in a fast-paced manufacturing environment.
- Excellent communication and interpersonal skills.
- Proficiency in Microsoft Office, with knowledge of Minitab and Syspro being an advantage.
- Strong understanding of GMP, validation, and regulatory standards.
This is an excellent opportunity for an experienced Quality Engineer ready to take the next step in their career. Don’t miss out – apply today!
For more information, call Kerry on 0860443981 or send your CV now.
