Job Overview
As a Quality Assurance Engineer, you will play a pivotal role in ensuring the successful functioning of our manufacturing facility. You will be responsible for supporting all quality aspects and reporting directly to the Quality Manager.
Core Responsibilities:
* Develop and implement solutions to sustain and improve our QMS.
* Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
* Interface with customers on new products, quality issues, and process qualifications.
* Develop and implement 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, such as 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 for this Role:
* 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 3 years' experience as a Quality Assurance Engineer within an injection molding or medical manufacturing environment or similar.