Job Description
We are seeking a Quality Assurance Engineer to join our team at a global leader in the manufacture of single-use medical devices.
The successful candidate will have a strong background in quality engineering, preferably in the medical device industry, and be proficient in statistical analysis techniques and software such as Minitab.
Key Responsibilities:
* Provide quality support to optimise production performance by addressing quality issues, identifying root causes, and implementing corrective and preventive actions.
* Lead and support quality engineering activities for new and existing products, including inspection plans, process validations, and risk management.
* Investigate and resolve quality issues using root cause analysis, CAPA implementation, and data-driven methodologies to enhance product and process quality.
Requirements:
* Degree (Level 8 or equivalent) in Quality Assurance or related field.
* Minimum 3 years' experience in Quality Engineering, ideally in medical device manufacturing.
* Strong knowledge of ISO 13485, ISO 14971, and QSR 21 CFR Part 820.