Quality Assurance Engineer
We are seeking a highly skilled Quality Assurance Engineer to join our team. In this role, you will play a crucial part in ensuring the quality and integrity of our products.
About the Role
This is an exciting opportunity for a motivated and experienced professional to take on a key role within our organisation. As a Quality Assurance Engineer, you will be responsible for:
* Developing and implementing solutions to sustain and improve our Quality Management System (QMS).
* Maintaining and supporting compliance to ISO 13485 and ISO 14001 systems standards.
* Interface with customers on new products, quality issues, and process qualifications.
* Developing and implementing process control programs to ensure customer requirements are met.
* Carry out process validations and qualification on products.
* Provide manufacturing support and Quality expertise in relation to manufacturing issues and product disposition.
* Perform quality engineering analysis to identify strategies to prevent quality non-conformances and minimize risk.
* Coordinate NCR / CAPA Process to ensure timely resolution and closure of issues.
* Lead training activities on Quality Procedures, e.g. Compliance, GMP, Audit Prep, and GDP.
* Support and represent the site during external audits and carry out internal audits.
* Trending and tracking of quality data to support quality improvements across the business.
* Support Environmental, Health, and Safety requirements, training, and regulations.
Requirements
* A third-level qualification in Engineering, Polymer Science, or equivalent.
* Manufacturing experience.
* Experience in statistical analysis (Minitab) / SPC / validations.
* Excellent interpersonal, communication, influencing, and facilitation skills.
* A minimum of three years' experience as a Quality Assurance Engineer within an injection moulding or medical manufacturing environment or similar.
Key Skills
* Quality engineer.
* Medical device.
* Injection moulding.
Become a Key Player
This role offers the opportunity to work with a dynamic team and contribute to the success of our organisation. If you have the required skills and experience, we encourage you to apply.