Seeking a Quality Engineer to provide quality assurance and control in operations, ensuring preventative measures and continuous improvement of products and processes.
The ideal candidate will advocate for quality performance within the business and ensure compliance with regulations and standards.
Key Responsibilities:
1. Collaborate with operations and business functions to achieve quality goals.
2. Approve NC builds and participate in problem-solving activities.
3. Develop and improve manufacturing processes for existing and new products.
4. Review change management activities and maintain KPIs for process quality monitoring.
5. Support execution and analysis of QATs and develop proficiency in statistical methods.
6. Advocate for Human Factor practices and familiarize with risk management concepts.
7. Develop understanding of optimization of inspection methods and sampling.
8. Support First Article Inspections and build proficiency in validation processes.
9. Participate in internal and external audits and assist in the development and review of process and equipment validation/qualification.
Requirements:
* Masters or Bachelor of Science, Engineering, or related subject.
* Previous industry experience desirable.
* Understanding of Med Device concepts desirable.
* Excellent communication skills and attention to detail.
* Strong analytical and problem-solving skills.
* Ability to work as part of a multi-site team with some travel required.
This is an exciting opportunity for a quality-focused individual to join our organization.