Senior Quality Leader
2 weeks ago
As a Senior Quality Engineer, you will play a pivotal role in driving quality excellence within our organization. This involves providing expert quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement.
Key Responsibilities:
- Lead the execution of initiatives and projects to enhance quality performance within the business and for our customers
- Ensure compliance to relevant regulations, including US and International Medical Device Regulations
- Interact with regulatory agencies (FDA, MoH, TUV, etc.) and maintain knowledge of regulatory requirements
- Foster strong relationships with cross-functional teams and external partners
- Develop and implement quality concepts, such as Risk Management, CAPA, Audits, and Statistics
Responsibilities also include:
Required Skills and Qualifications- Strong knowledge of quality concepts, including risk management, corrective action, audits, and statistics
- Experience interacting with regulatory agencies and understanding medical device regulations
- Excellent communication, project management, and influencing skills
- Able to manage multiple tasks simultaneously and represent the Quality function with project teams
- Highly developed problem-solving skills and analytical abilities
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