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Senior Product Assurance Specialist
2 weeks ago
We are seeking a highly skilled Staff Engineer to join our organization. This is a 23-month fixed-term contract that will allow you to utilize your expertise in quality assurance, control, and preventative activities to drive continuous improvement of internal products and processes.
Primary Responsibilities- Provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes.
- Support supplier quality issues impacting daily operations.
- Advocate and lead initiatives to enhance quality performance within the business and for customers.
- Mentor and provide technical direction across multiple areas.
- Ensure compliance with regulations and standards.
The ideal candidate will have experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) and a strong understanding of US and International Medical Device Regulations. They will also possess a solid knowledge of Quality concepts (Risk Management, CAPA, Audits, Statistics) and excellent communication, project management, and influencing skills.
Requirements
The following skills and qualifications are required:
- Strong understanding of US and International Medical Device Regulations.
- Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
- Solid knowledge of Quality concepts (Risk Management, CAPA, Audits, Statistics).
- Excellent communication, project management, and influencing skills.
