**Quality Assurance Specialist - Medical Devices**
In this pivotal role, you will be instrumental in driving the successful functioning of our manufacturing facility by ensuring seamless quality control processes. As a Quality Assurance Specialist, you will report directly to the Quality Manager and work closely with cross-functional teams to achieve exceptional quality objectives.
Your primary responsibilities will include:
* Developing and implementing strategies to sustain and improve our Quality Management System (QMS).
* Maintaining and supporting compliance to ISO 13485 and ISO 14001 systems standards.
* Coordinating with customers on new product launches, quality issues, and process qualifications.
* Designing and implementing process control programs to ensure customer requirements are met.
* Carrying out process validations and qualification on products.
* Providing manufacturing support and quality expertise on manufacturing issues and product disposition.
You will also be responsible for:
* Performing quality engineering analysis to identify strategies to prevent quality non-conformances and minimize risk.
* Leading training activities on quality procedures, such as compliance, GMP, audit prep, and GDP.
* Representing the site during external audits and carrying out internal audits.
* Trending and tracking quality data to support quality improvements across the business.
To be successful in this role, you will need:
* A third-level qualification in Engineering, Polymer Science, or equivalent.
* Manufacturing experience, preferably in an injection molding or medical device environment.
* Experience in statistical analysis (Minitab) / SPC / validations.
* Excellent interpersonal, communication, influencing, and facilitation skills.
If you have a passion for delivering exceptional quality outcomes and are committed to excellence, we encourage you to apply for this exciting opportunity.