Quality Assurance Specialist
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team. In this role, you will play a key part in ensuring the quality of our products and services.
Job Description
Key Responsibilities:
* Develop and implement solutions to sustain and improve our Quality Management System (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 Non-Conforming Report (NCR) / Corrective Action Preventive Action (CAPA) Process to ensure timely resolution and closure of issues
* Lead training activities on Quality Procedures e.g. Compliance, Good Manufacturing Practice (GMP), Audit Preparation and Good Distribution Practice (GDP)
* Support and represent the site during external audits and carry out internal audits
* Trend and track quality data to support quality improvements across the business
* Support Environmental, Health and Safety (EHS) requirements, training and regulations
Requirements
Essential Qualifications:
* Third level qualification in Engineering, Polymer Science or equivalent
* Manufacturing experience
* Experience in statistical analysis (Minitab) / Statistical Process Control (SPC) / validations
* Excellent interpersonal, communication, influencing and facilitation skills
Desirable Experience:
* A minimum of 3 years experience as a Quality Assurance Engineer within an injection moulding or medical manufacturing environment or similar