Job Title: Quality Engineer - Medical Device Manufacturing
About the Role:
As a Quality Engineer, you will play a crucial role in ensuring the highest quality standards are met across production processes.
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.