Job Title: Quality Engineer
We are seeking a highly skilled Quality Engineer to join our Operations team. As a key member of the team, you will play a pivotal role in ensuring the quality and compliance of our manufacturing processes, contributing to the delivery of medical devices that change lives.
About Our Company
Our company has developed an effective product on the market for both long-term and newly diagnosed chronic rhinitis patients.
Responsibilities
1. Quality Assurance: Develop, implement, and maintain quality assurance procedures and methods for control of materials and finished goods.
2. Team Collaboration: Work as a key member of the operations team and with suppliers to ensure quality standards are met and maintained.
3. Product Control: Develop and execute product quality control plans, documents, and procedures.
4. Risk Analysis: Provide input to risk analyses and Process Failure Mode Effect Analysis (pFMEAs) including with suppliers.
5. Quality Improvement: Implement and enhance quality principles, gather and analyse quality data to support product/process improvement activities.
6. Manufacturing Oversight: Oversee manufacturing-related quality events in line with GMP and internal procedures, including process defects, CAPA, and complaint investigations.
7. Corrective Actions: Disposition non-conforming material and work with manufacturers and suppliers to implement corrective and preventive actions.
8. Quality Guidance: Provide quality guidance as an integral member of the operations team, influencing manufacturing activities.
9. Process Validation: Provide quality input into process validation activities.
Requirements
1. Education: BE/BS Degree. A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
2. Experience: At least three years Quality Engineering experience or related role within the medical device industry.
3. Industry Knowledge: Experienced working in a medical device manufacturing environment complying with Good Manufacturing Practices.